CS300

INTRA-AORTIC BALLOON PUMP

This device is manufactured by CARDIAC ASSIST MAQUET CARDIOVASCULAR, DATASCOPE CORP, DATASCOPE CORP CARDIAC ASSIST DIVISION, DATASCOPE CORPORATION, DATASCOPR CORP, GETINGE / DATASCOPE CORP, MAQUET, MAQUET / DATASCOPE CORP, MAQUET CARDIOVASCULAR, MAQUET CARDIOVASCULAR DATASCOPE CORP, MAQUET DATASCOPE CORPORATION.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-06-13 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Charge
2024-02-16 Malfunction No Clinical Signs, Symptoms or Conditions Battery Problem, Material Integrity Problem
2024-01-02 Malfunction Insufficient Information Incorrect, Inadequate or Imprecise Result or Readings
2023-10-10 Malfunction Insufficient Information, No Clinical Signs, Symptoms or Conditions Erratic or Intermittent Display
2023-01-05 Malfunction No Clinical Signs, Symptoms or Conditions No Display/Image
2022-11-07 Malfunction No Clinical Signs, Symptoms or Conditions Appropriate Term/Code Not Available
2021-09-30 Malfunction No Clinical Signs, Symptoms or Conditions Display or Visual Feedback Problem
2020-05-12 Malfunction None Electrical /Electronic Property Problem
2020-02-03 Malfunction None Circuit Failure, Installation-Related Problem
2019-11-11 Malfunction None Display or Visual Feedback Problem, Battery Problem
2019-11-06 Malfunction None Unexpected Shutdown
2019-10-31 Malfunction None Erratic or Intermittent Display, Display or Visual Feedback Problem
2019-10-18 Malfunction None Failure to Charge, Power Problem
2019-10-11 Malfunction None Electrical /Electronic Property Problem
2019-10-11 Malfunction None Gas/Air Leak
2019-10-02 Malfunction None Battery Problem
2019-09-24 Malfunction None Gas/Air Leak
2019-09-19 Malfunction None Battery Problem
2019-09-17 Malfunction None Unexpected Shutdown
2019-09-11 Malfunction None Material Twisted/Bent, Noise, Audible
2019-09-11 Malfunction None Appropriate Term/Code Not Available, Unexpected Shutdown
2019-09-11 Malfunction None Erratic or Intermittent Display
2019-09-08 Malfunction None Failure to Power Up
2019-09-06 Malfunction None Premature Discharge of Battery
2019-09-05 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-09-04 Malfunction None Break
2019-09-04 Malfunction None Premature Discharge of Battery
2019-09-03 Malfunction None Failure to Sense
2019-09-03 Malfunction None Appropriate Term/Code Not Available
2019-09-02 Malfunction None Appropriate Term/Code Not Available
2019-08-30 Malfunction None Appropriate Term/Code Not Available
2019-08-30 Malfunction None Gas/Air Leak
2019-08-30 Malfunction None Premature Discharge of Battery
2019-08-29 Malfunction None Failure to Sense
2019-08-29 Malfunction None Unexpected Shutdown
2019-08-28 Malfunction None Inflation Problem, Failure to Sense
2019-08-28 Malfunction None Output below Specifications
2019-08-28 Malfunction None Unexpected Shutdown
2019-08-28 Malfunction None Premature Discharge of Battery
2019-08-28 Malfunction None Premature Discharge of Battery
2019-08-27 Malfunction None Connection Problem
2019-08-27 Malfunction None Appropriate Term/Code Not Available
2019-08-26 Malfunction None Premature Discharge of Battery
2019-08-26 Malfunction None Appropriate Term/Code Not Available
2019-08-26 Malfunction None Premature Discharge of Battery
2019-08-25 Malfunction None Unexpected Shutdown
2019-08-25 Malfunction None Display or Visual Feedback Problem
2019-08-24 Malfunction None No Display/Image
2019-08-24 Malfunction None Display or Visual Feedback Problem, Unexpected Shutdown
2019-08-23 Malfunction None Display or Visual Feedback Problem
2019-08-23 Malfunction None Unexpected Shutdown
2019-08-23 Malfunction None Component Misassembled
2019-08-22 Malfunction None Premature Discharge of Battery
2019-08-22 Malfunction None Unexpected Shutdown
2019-08-22 Malfunction None No Display/Image
2019-08-22 Malfunction None Electrical /Electronic Property Problem, Device Contamination with Chemical or Other Material
2019-08-21 Malfunction None Premature Discharge of Battery
2019-08-21 Malfunction None Appropriate Term/Code Not Available
2019-08-20 Malfunction None Failure to Sense
2019-08-20 Malfunction None Electrical /Electronic Property Problem
2019-08-20 Malfunction None Gas/Air Leak
2019-08-20 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-08-20 Malfunction None Gas/Air Leak
2019-08-20 Malfunction None Failure to Sense
2019-08-20 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-08-20 Malfunction None Leak/Splash
2019-08-20 Malfunction None Output below Specifications
2019-08-19 Malfunction None Premature Discharge of Battery
2019-08-19 Malfunction None Break
2019-08-19 Malfunction None Failure to Power Up
2019-08-19 Malfunction None Premature Discharge of Battery
2019-08-16 Malfunction None Break
2019-08-16 Injury None Device Contamination with Body Fluid, Adverse Event Without Identified Device or Use Problem
2019-08-16 Malfunction None Electrical /Electronic Property Problem
2019-08-15 Malfunction None Leak/Splash
2019-08-15 Malfunction None No Display/Image
2019-08-15 Malfunction None Premature Discharge of Battery
2019-08-14 Malfunction None Circuit Failure
2019-08-14 Malfunction None Premature Discharge of Battery
2019-08-13 Malfunction None Premature Discharge of Battery
2019-08-13 Malfunction None Failure to Sense
2019-08-13 Malfunction None Failure to Sense
2019-08-12 Malfunction None Erratic or Intermittent Display
2019-08-09 Malfunction None Gas/Air Leak
2019-08-08 Malfunction None Premature Discharge of Battery
2019-08-08 Malfunction None No Display/Image
2019-08-08 Malfunction None Unexpected Shutdown
2019-08-08 Malfunction None Failure to Sense
2019-08-08 Malfunction None Unexpected Shutdown
2019-08-07 Malfunction None Inability to Auto-Fill
2019-08-07 Malfunction None Power Problem
2019-08-07 Malfunction None Electrical /Electronic Property Problem
2019-08-07 Malfunction None Gas/Air Leak
2019-08-07 Malfunction None Erratic or Intermittent Display
2019-08-06 Malfunction None Failure to Sense
2019-08-05 Malfunction None Leak/Splash
2019-08-05 Malfunction None Electrical /Electronic Property Problem
2019-08-05 Malfunction None Premature Discharge of Battery
2019-08-05 Malfunction None Erratic or Intermittent Display
2019-08-05 Malfunction None No Display/Image
2019-08-05 Malfunction None Premature Discharge of Battery
2019-08-04 Malfunction None Inability to Auto-Fill
2019-08-02 Malfunction None Inability to Auto-Fill
2019-08-02 Malfunction None Display or Visual Feedback Problem, Failure to Power Up, Noise, Audible, Unexpected Shutdown
2019-08-02 Malfunction None Premature Discharge of Battery
2019-08-01 Malfunction None Unexpected Shutdown
2019-08-01 Malfunction None Failure to Power Up
2019-08-01 Malfunction None Output below Specifications
2019-08-01 Malfunction None Premature Discharge of Battery
2019-07-31 Malfunction None Display or Visual Feedback Problem
2019-07-31 Malfunction None Battery Problem
2019-07-30 Malfunction None Device Alarm System, Failure to Zero, Noise, Audible
2019-07-30 Malfunction None Failure to Sense, Appropriate Term/Code Not Available, Noise, Audible, Unexpected Shutdown
2019-07-29 Malfunction None Appropriate Term/Code Not Available
2019-07-29 Malfunction None Output below Specifications
2019-07-29 Malfunction None Unexpected Shutdown
2019-07-29 Malfunction None Failure to Power Up
2019-07-29 Malfunction None Failure to Sense
2019-07-29 Malfunction None Unexpected Shutdown
2019-07-29 Malfunction None Corroded
2019-07-28 Malfunction None Electrical /Electronic Property Problem
2019-07-27 Malfunction None Inability to Auto-Fill, Appropriate Term/Code Not Available
2019-07-26 Malfunction None Failure to Sense
2019-07-25 Malfunction None Gas/Air Leak
2019-07-24 Malfunction None Premature Discharge of Battery
2019-07-24 Malfunction None Failure to Sense, Appropriate Term/Code Not Available
2019-07-24 Malfunction None Charging Problem
2019-07-23 Malfunction None Premature Discharge of Battery
2019-07-23 Malfunction None Unexpected Shutdown
2019-07-23 Malfunction None Appropriate Term/Code Not Available
2019-07-23 Malfunction None No Display/Image
2019-07-23 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-07-22 Malfunction None Leak/Splash
2019-07-22 Malfunction None Electrical /Electronic Property Problem
2019-07-22 Malfunction None Failure to Sense
2019-07-20 Malfunction None Failure to Power Up
2019-07-20 Malfunction None Failure to Sense
2019-07-19 Malfunction None Erratic or Intermittent Display
2019-07-18 Malfunction None Output below Specifications, Appropriate Term/Code Not Available
2019-07-18 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-18 Malfunction None Inaccurate Synchronization, Calibration Problem
2019-07-17 Malfunction None No Display/Image, Pumping Stopped, Unexpected Shutdown
2019-07-17 Malfunction None Premature Discharge of Battery
2019-07-17 Malfunction None Inability to Auto-Fill
2019-07-16 Malfunction None Output below Specifications
2019-07-13 Injury None Break, Unintended Collision, Connection Problem
2019-07-13 Malfunction None Output Problem, Unexpected Shutdown
2019-07-12 Malfunction None Inflation Problem, Failure to Sense
2019-07-11 Malfunction None Premature Discharge of Battery
2019-07-11 Malfunction None Inflation Problem
2019-07-11 Malfunction None Premature Discharge of Battery
2019-07-11 Malfunction None Premature Discharge of Battery
2019-07-10 Malfunction None Calibration Problem, Appropriate Term/Code Not Available
2019-07-10 Malfunction None Power Problem
2019-07-10 Malfunction None Break, Leak/Splash
2019-07-09 Malfunction None Battery Problem
2019-07-09 Malfunction None Restricted Flow rate
2019-07-08 Malfunction None Inability to Auto-Fill
2019-07-08 Malfunction None Inability to Auto-Fill
2019-07-08 Malfunction None Failure to Sense
2019-07-08 Malfunction None Electrical /Electronic Property Problem
2019-07-08 Malfunction None Premature Discharge of Battery
2019-07-08 Malfunction None Gas/Air Leak
2019-07-05 Malfunction None Premature Discharge of Battery
2019-07-05 Injury None Leak/Splash, Device Contamination with Body Fluid
2019-07-04 Malfunction None Unexpected Shutdown
2019-07-04 Malfunction None Pumping Stopped
2019-07-04 Malfunction None Display or Visual Feedback Problem, Failure to Sense
2019-07-03 Malfunction None Output below Specifications
2019-07-03 Malfunction None Display or Visual Feedback Problem
2019-07-02 Malfunction None Inability to Auto-Fill
2019-07-02 Malfunction None Electrical /Electronic Property Problem
2019-07-02 Malfunction None Display or Visual Feedback Problem
2019-07-01 Malfunction None Calibration Problem
2019-07-01 Malfunction None Display Difficult to Read
2019-07-01 Malfunction None Inability to Auto-Fill
2019-07-01 Malfunction None Inappropriate or Unexpected Reset
2019-06-28 Malfunction None Battery Problem
2019-06-28 Malfunction None Charging Problem
2019-06-27 Malfunction None Premature Discharge of Battery
2019-06-27 Malfunction None Gas/Air Leak
2019-06-27 Malfunction None Gas/Air Leak
2019-06-26 Malfunction None Unexpected Shutdown
2019-06-26 Malfunction None Failure to Power Up, Audible Prompt/Feedback Problem
2019-06-25 Malfunction None Leak/Splash
2019-06-25 Malfunction None Failure to Sense
2019-06-25 Malfunction None Premature Discharge of Battery
2019-06-25 Malfunction None Premature Discharge of Battery
2019-06-25 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-06-25 Malfunction None Premature Discharge of Battery
2019-06-24 Malfunction None Failure to Sense
2019-06-23 Malfunction None Unexpected Shutdown
2019-06-21 Death None Unexpected Shutdown
2019-06-21 Malfunction None Premature Discharge of Battery
2019-06-21 Malfunction None Erratic or Intermittent Display
2019-06-21 Malfunction None Appropriate Term/Code Not Available
2019-06-21 Malfunction None Device Alarm System, Loss of Power, Incorrect, Inadequate or Imprecise Result or Readings
2019-06-20 Malfunction None Premature Discharge of Battery
2019-06-20 Death None Failure to Sense
2019-06-20 Malfunction None Failure to Zero, Failure to Calibrate
2019-06-18 Malfunction None Erratic or Intermittent Display
2019-06-18 Malfunction None Failure to Sense
2019-06-17 Malfunction None Gas/Air Leak
2019-06-16 Malfunction None Electrical /Electronic Property Problem
2019-06-16 Malfunction None Failure to Sense
2019-06-14 Malfunction None Premature Discharge of Battery
2019-06-14 Malfunction None Erratic or Intermittent Display
2019-06-13 Malfunction None No Display/Image
2019-06-13 Malfunction None Failure to Power Up
2019-06-12 Malfunction None Appropriate Term/Code Not Available
2019-06-12 Malfunction None Unexpected Shutdown
2019-06-12 Malfunction None Material Twisted/Bent
2019-06-12 Malfunction None Erratic or Intermittent Display
2019-06-11 Malfunction None Gas/Air Leak
2019-06-11 Malfunction None No Display/Image
2019-06-11 Malfunction None Unexpected Shutdown
2019-06-10 Malfunction None Erratic or Intermittent Display
2019-06-07 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-06-07 Malfunction None Battery Problem
2019-06-07 Malfunction None No Display/Image
2019-06-06 Malfunction None Inability to Auto-Fill
2019-06-06 Malfunction None Battery Problem
2019-06-06 Malfunction None Premature Discharge of Battery
2019-06-06 Malfunction None Erratic or Intermittent Display
2019-06-06 Malfunction None Premature Discharge of Battery
2019-06-06 Malfunction None Inability to Auto-Fill
2019-06-05 Malfunction None Moisture or Humidity Problem, Audible Prompt/Feedback Problem
2019-06-05 Malfunction None Gas/Air Leak
2019-06-05 Malfunction None Erratic or Intermittent Display
2019-06-05 Malfunction None Inability to Auto-Fill
2019-06-04 Malfunction None Failure to Power Up, Audible Prompt/Feedback Problem
2019-06-03 Malfunction None Erratic or Intermittent Display
2019-06-01 Malfunction None Failure to Sense
2019-06-01 Malfunction None Erratic or Intermittent Display
2019-05-31 Malfunction None Failure to Zero
2019-05-31 Malfunction None Output below Specifications
2019-05-30 Malfunction None Output below Specifications
2019-05-30 Malfunction None Inability to Auto-Fill
2019-05-30 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-05-29 Malfunction None Unexpected Shutdown
2019-05-29 Malfunction None Failure to Sense
2019-05-28 Malfunction None Erratic or Intermittent Display
2019-05-24 Malfunction None Leak/Splash
2019-05-24 Malfunction None No Display/Image
2019-05-24 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Defective Component
2019-05-24 Malfunction None Failure to Sense
2019-05-23 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-05-23 Malfunction None Calibration Problem
2019-05-22 Malfunction None Premature Discharge of Battery
2019-05-22 Malfunction None Battery Problem
2019-05-22 Malfunction None Failure to Sense
2019-05-21 Malfunction None Display Difficult to Read
2019-05-21 Malfunction None No Device Output, Incorrect, Inadequate or Imprecise Result or Readings
2019-05-21 Malfunction None Premature Discharge of Battery
2019-05-20 Malfunction None Erratic or Intermittent Display
2019-05-20 Malfunction None Battery Problem
2019-05-19 Malfunction None Pumping Stopped
2019-05-17 Malfunction None Display or Visual Feedback Problem
2019-05-16 Malfunction None Calibration Problem
2019-05-16 Malfunction None Erratic or Intermittent Display
2019-05-16 Malfunction None Display or Visual Feedback Problem
2019-05-16 Malfunction None Display or Visual Feedback Problem, Intermittent Communication Failure
2019-05-16 Malfunction None Failure to Sense, Failure to Zero
2019-05-16 Malfunction None Failure to Sense
2019-05-16 Malfunction None Inability to Auto-Fill
2019-05-16 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Material Protrusion/Extrusion
2019-05-16 Malfunction None Inability to Auto-Fill, Electrical /Electronic Property Problem, Failure to Power Up
2019-05-15 Malfunction None Erratic or Intermittent Display
2019-05-15 Malfunction None Unexpected Shutdown
2019-05-15 Malfunction None Output below Specifications, Pressure Problem
2019-05-14 Malfunction None Calibration Problem
2019-05-13 Malfunction None Premature Discharge of Battery
2019-05-13 Malfunction None Gas/Air Leak
2019-05-13 Malfunction None Inability to Auto-Fill, Appropriate Term/Code Not Available
2019-05-11 Malfunction None Contamination, Electrical /Electronic Property Problem
2019-05-10 Malfunction None No Display/Image, Unexpected Shutdown
2019-05-10 Malfunction None Unexpected Shutdown
2019-05-09 Malfunction None Device Displays Incorrect Message
2019-05-09 Malfunction None Battery Problem, Unexpected Shutdown
2019-05-09 Malfunction None Display or Visual Feedback Problem
2019-05-08 Malfunction None Inability to Auto-Fill, Output below Specifications, Appropriate Term/Code Not Available
2019-05-08 Malfunction None Failure to Power Up
2019-05-07 Malfunction None Power Problem
2019-05-07 Malfunction None Gas/Air Leak
2019-05-06 Malfunction None No Display/Image, Display or Visual Feedback Problem, Pumping Stopped, Audible Prompt/Feedback Problem
2019-05-06 Injury None Loss of Power, Failure to Reset
2019-05-06 Malfunction None Failure to Sense
2019-05-06 Malfunction None Output below Specifications
2019-05-06 Malfunction None Gas/Air Leak, Audible Prompt/Feedback Problem
2019-05-04 Malfunction None Failure to Sense
2019-05-04 Malfunction None Failure to Power Up, Appropriate Term/Code Not Available, Unexpected Shutdown
2019-05-02 Malfunction None Output Problem
2019-05-02 Malfunction None Failure to Sense
2019-05-01 Malfunction None Unable to Obtain Readings
2019-05-01 Malfunction None Battery Problem, Unexpected Shutdown
2019-05-01 Malfunction None Leak/Splash
2019-05-01 Malfunction None Image Display Error/Artifact
2019-04-30 Malfunction None Electrical /Electronic Property Problem
2019-04-28 Malfunction None Leak/Splash
2019-04-26 Malfunction None No Device Output
2019-04-26 Malfunction None Display or Visual Feedback Problem
2019-04-26 Malfunction None Inability to Auto-Fill, Failure to Sense
2019-04-25 Malfunction None Display or Visual Feedback Problem
2019-04-25 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-24 Malfunction None Charging Problem, Communication or Transmission Problem
2019-04-24 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-04-24 Malfunction None Noise, Audible
2019-04-23 Malfunction None Connection Problem
2019-04-23 Malfunction None Break
2019-04-23 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-23 Malfunction None Use of Incorrect Control/Treatment Settings
2019-04-23 Malfunction None Gas/Air Leak
2019-04-22 Malfunction None Battery Problem
2019-04-22 Malfunction None Loss of Power
2019-04-22 Malfunction None Inability to Auto-Fill, Appropriate Term/Code Not Available
2019-04-20 Malfunction None False Alarm, Failure to Sense
2019-04-20 Malfunction None Failure to Sense
2019-04-20 Malfunction None Output below Specifications
2019-04-20 Malfunction None Moisture or Humidity Problem
2019-04-19 Malfunction None Calibration Problem
2019-04-18 Malfunction None Device Displays Incorrect Message
2019-04-18 Malfunction None Leak/Splash
2019-04-18 Malfunction None Failure to Sense
2019-04-18 Malfunction None Power Problem
2019-04-18 Malfunction None Electrical /Electronic Property Problem, Appropriate Term/Code Not Available
2019-04-18 Malfunction None Premature Discharge of Battery
2019-04-17 Malfunction None Filling Problem
2019-04-17 Malfunction None Failure to Sense
2019-04-17 Malfunction None Charging Problem
2019-04-17 Malfunction None Leak/Splash
2019-04-16 Malfunction None Power Problem
2019-04-12 Malfunction None Inability to Auto-Fill, Device Displays Incorrect Message
2019-04-12 Malfunction None Display or Visual Feedback Problem, Power Problem
2019-04-12 Malfunction None Unexpected Shutdown
2019-04-12 Malfunction None Display or Visual Feedback Problem, Power Problem
2019-04-11 Malfunction None Device Alarm System
2019-04-11 Malfunction None Optical Distortion
2019-04-11 Malfunction None Failure to Sense
2019-04-11 Malfunction None Loss of Power, Unexpected Shutdown
2019-04-11 Malfunction None Display or Visual Feedback Problem, Pumping Stopped
2019-04-10 Malfunction None Unable to Obtain Readings, Computer Operating System Problem
2019-04-10 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-10 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-09 Malfunction None Pumping Stopped, Gas/Air Leak
2019-04-09 Malfunction None Break, Therapeutic or Diagnostic Output Failure
2019-04-09 Malfunction None Protective Measures Problem
2019-04-06 Malfunction None Loss of Power
2019-04-06 Malfunction None Moisture or Humidity Problem
2019-04-06 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-05 Malfunction None Electrical /Electronic Property Problem, Protective Measures Problem
2019-04-05 Malfunction None Premature Discharge of Battery
2019-04-05 Malfunction None Decrease in Suction
2019-04-04 Malfunction None Device Displays Incorrect Message
2019-04-04 Malfunction None Defective Device
2019-04-04 Malfunction None Premature Discharge of Battery, Therapeutic or Diagnostic Output Failure
2019-04-04 Malfunction None Decrease in Suction
2019-04-03 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-04-03 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-04-03 Malfunction None Loose or Intermittent Connection, Incorrect, Inadequate or Imprecise Result or Readings
2019-04-03 Malfunction None Failure to Power Up
2019-04-02 Malfunction None Display or Visual Feedback Problem
2019-04-02 Malfunction None Device Displays Incorrect Message
2019-04-02 Malfunction None Display or Visual Feedback Problem, Loss of Power, Unexpected Shutdown, Audible Prompt/Feedback Problem
2019-04-01 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Device Displays Incorrect Message
2019-04-01 Malfunction None Display or Visual Feedback Problem
2019-04-01 Malfunction None Erratic or Intermittent Display, Display or Visual Feedback Problem, Connection Problem
2019-04-01 Malfunction None Failure to Sense
2019-04-01 Malfunction None Communication or Transmission Problem
2019-03-31 Malfunction None Inability to Auto-Fill
2019-03-30 Malfunction None Loss of Power, Charging Problem
2019-03-29 Malfunction None Unexpected Shutdown
2019-03-28 Malfunction None Display or Visual Feedback Problem, Leak/Splash
2019-03-28 Malfunction None Leak/Splash
2019-03-28 Malfunction None Defective Component
2019-03-28 Malfunction None Display or Visual Feedback Problem
2019-03-27 Malfunction None Display or Visual Feedback Problem
2019-03-27 Malfunction None Output Problem
2019-03-27 Malfunction None Inability to Auto-Fill
2019-03-27 Malfunction None Defective Device
2019-03-27 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-26 Malfunction None Display or Visual Feedback Problem
2019-03-26 Malfunction None Output Problem
2019-03-26 Malfunction None Image Display Error/Artifact
2019-03-26 Malfunction None Installation-Related Problem, Pressure Problem
2019-03-26 Malfunction None Defective Component
2019-03-25 Malfunction None Display or Visual Feedback Problem
2019-03-25 Malfunction None Charging Problem
2019-03-25 Injury None Device Alarm System, No Audible Alarm, No Display/Image, Pumping Stopped, Therapeutic or Diagnostic Output Failure
2019-03-23 Malfunction None Inappropriate Waveform, Noise, Audible
2019-03-23 Malfunction None Image Display Error/Artifact, Pumping Stopped, Material Integrity Problem, Device Fell
2019-03-23 Malfunction None Charging Problem
2019-03-22 Malfunction None Charging Problem
2019-03-21 Malfunction None Protective Measures Problem
2019-03-21 Malfunction None Therapeutic or Diagnostic Output Failure
2019-03-21 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-21 Malfunction None Therapeutic or Diagnostic Output Failure
2019-03-21 Malfunction None Therapeutic or Diagnostic Output Failure
2019-03-20 Malfunction None Material Discolored, Display or Visual Feedback Problem, Failure to Power Up
2019-03-20 Malfunction None Premature Discharge of Battery
2019-03-19 Malfunction None Loss of Power, Activation, Positioning or Separation Problem
2019-03-19 Malfunction None Gas/Air Leak
2019-03-18 Malfunction None Moisture Damage, Defective Device
2019-03-18 Malfunction None Moisture Damage, Output Problem
2019-03-18 Malfunction None Loss of Power, Battery Problem
2019-03-15 Malfunction None Battery Problem
2019-03-15 Malfunction None Charging Problem
2019-03-15 Malfunction None Difficult to Open or Close, Manufacturing, Packaging or Shipping Problem, Mechanical Jam
2019-03-14 Malfunction None Loss of Power, Unexpected Shutdown
2019-03-14 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-14 Malfunction None Decrease in Suction, Moisture Damage
2019-03-14 Malfunction None No Display/Image
2019-03-13 Malfunction None Premature Discharge of Battery
2019-03-13 Malfunction None Energy Output Problem, Incorrect, Inadequate or Imprecise Result or Readings
2019-03-13 Malfunction None Failure of Device to Self-Test
2019-03-12 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-12 Malfunction None Battery Problem
2019-03-12 Malfunction None Inability to Auto-Fill
2019-03-12 Malfunction None Intermittent Energy Output
2019-03-11 Malfunction None Filling Problem
2019-03-11 Malfunction None Inability to Auto-Fill
2019-03-11 Malfunction None Premature Discharge of Battery
2019-03-11 Malfunction None Display or Visual Feedback Problem
2019-03-11 Malfunction None Battery Problem
2019-03-11 Malfunction None Device Displays Incorrect Message
2019-03-11 Malfunction None Failure of Device to Self-Test
2019-03-11 Malfunction None Image Display Error/Artifact
2019-03-08 Malfunction None Display or Visual Feedback Problem, Leak/Splash
2019-03-08 Malfunction None Device Emits Odor
2019-03-07 Malfunction None Gas/Air Leak
2019-03-07 Malfunction None Gas/Air Leak
2019-03-07 Malfunction None Display or Visual Feedback Problem
2019-03-07 Malfunction None Failure of Device to Self-Test
2019-03-06 Malfunction None Erratic or Intermittent Display, No Display/Image
2019-03-06 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-06 Malfunction None Failure to Sense, Protective Measures Problem
2019-03-06 Malfunction None Protective Measures Problem
2019-03-05 Malfunction None Device Alarm System
2019-03-04 Malfunction None Inability to Auto-Fill
2019-03-04 Malfunction None Device Displays Incorrect Message
2019-03-04 Malfunction None Break, Device Damaged Prior to Use
2019-03-04 Malfunction None Failure of Device to Self-Test
2019-03-04 Malfunction None Display or Visual Feedback Problem, Loss of Power, Failure to Power Up
2019-03-04 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-03-03 Malfunction None Increase in Pressure
2019-03-02 Malfunction None Device Displays Incorrect Message, Output below Specifications
2019-03-01 Malfunction None Image Display Error/Artifact
2019-03-01 Malfunction None Device Displays Incorrect Message
2019-03-01 Malfunction None Failure to Sense
2019-02-28 Malfunction None Inability to Auto-Fill
2019-02-28 Malfunction None Display or Visual Feedback Problem
2019-02-28 Malfunction None Protective Measures Problem
2019-02-28 Malfunction None Loss of Power, Battery Problem
2019-02-28 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-02-27 Malfunction None Display or Visual Feedback Problem
2019-02-26 Malfunction None Loss of Power
2019-02-26 Malfunction None Premature Discharge of Battery, Failure to Power Up, Charging Problem
2019-02-26 Malfunction None No Display/Image
2019-02-26 Malfunction None Battery Problem, Failure of Device to Self-Test
2019-02-26 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-02-25 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-02-25 Malfunction None Image Display Error/Artifact
2019-02-25 Malfunction None Electrical Power Problem
2019-02-25 Malfunction None Break
2019-02-25 Malfunction None Display or Visual Feedback Problem
2019-02-22 Malfunction None Filling Problem
2019-02-22 Malfunction None Failure to Run on Battery, Loss of Power
2019-02-22 Malfunction None Communication or Transmission Problem
2019-02-21 Malfunction None Inflation Problem
2019-02-20 Malfunction None Noise, Audible, Physical Resistance/Sticking
2019-02-20 Malfunction None Loss of Power, Failure to Power Up
2019-02-19 Malfunction None Therapeutic or Diagnostic Output Failure
2019-02-19 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-02-18 Malfunction None Gas/Air Leak
2019-02-18 Malfunction None Output Problem
2019-02-16 Malfunction None Protective Measures Problem
2019-02-15 Malfunction None Display or Visual Feedback Problem
2019-02-15 Malfunction None Device Displays Incorrect Message
2019-02-15 Malfunction None Display or Visual Feedback Problem, Failure to Power Up
2019-02-14 Malfunction None Failure to Power Up, Communication or Transmission Problem
2019-02-14 Malfunction None Failure of Device to Self-Test
2019-02-13 Malfunction None Inability to Auto-Fill, Display or Visual Feedback Problem, Leak/Splash, Loose or Intermittent Connection
2019-02-13 Malfunction None Device Alarm System, Material Rupture
2019-02-13 Malfunction None Gas/Air Leak
2019-02-13 Malfunction None Device Alarm System
2019-02-13 Malfunction None Defective Component
2019-02-12 Malfunction None Protective Measures Problem
2019-02-12 Malfunction None Leak/Splash
2019-02-11 Malfunction None Failure to Power Up
2019-02-11 Malfunction None No Display/Image
2019-02-11 Malfunction None Battery Problem
2019-02-08 Malfunction None Unintended Ejection, Incorrect, Inadequate or Imprecise Result or Readings
2019-02-08 Malfunction None No Display/Image
2019-02-08 Malfunction None Display or Visual Feedback Problem
2019-02-07 Malfunction None Device Displays Incorrect Message
2019-02-07 Malfunction None Fluid/Blood Leak, Failure to Calibrate
2019-02-07 Malfunction None Device Displays Incorrect Message
2019-02-07 Malfunction None No Display/Image
2019-02-06 Malfunction None Failure to Sense
2019-02-06 Malfunction None Battery Problem
2019-02-06 Malfunction None Leak/Splash
2019-02-06 Malfunction None Defective Device
2019-02-05 Malfunction None Display or Visual Feedback Problem, Loose or Intermittent Connection
2019-02-05 Malfunction None Failure to Charge, Battery Problem, Appropriate Term/Code Not Available
2019-02-05 Malfunction None Charging Problem
2019-02-05 Malfunction None Display or Visual Feedback Problem, Electrical Shorting
2019-02-04 Malfunction None Battery Problem
2019-02-04 Malfunction None Gas/Air Leak
2019-02-01 Malfunction None Gas/Air Leak
2019-02-01 Malfunction None Failure of Device to Self-Test
2019-02-01 Malfunction None Device Displays Incorrect Message
2019-01-31 Malfunction None Break, Electrical /Electronic Property Problem, Battery Problem
2019-01-31 Malfunction None Break, Display or Visual Feedback Problem, Electrical /Electronic Property Problem, Battery Problem, Charging Problem
2019-01-31 Malfunction None Failure of Device to Self-Test
2019-01-31 Malfunction None Display or Visual Feedback Problem
2019-01-31 Malfunction None Device Displays Incorrect Message
2019-01-30 Malfunction None Failure of Device to Self-Test
2019-01-30 Malfunction None Loss of Power
2019-01-30 Malfunction None Battery Problem
2019-01-29 Malfunction None Protective Measures Problem
2019-01-28 Death None Defective Component
2019-01-28 Malfunction None Leak/Splash
2019-01-28 Malfunction None Device Displays Incorrect Message
2019-01-25 Malfunction None Display or Visual Feedback Problem
2019-01-25 Malfunction None Break
2019-01-25 Malfunction None Decrease in Suction
2019-01-25 Malfunction None Inability to Auto-Fill
2019-01-24 Malfunction None Failure to Analyze Signal
2019-01-23 Malfunction None Device Displays Incorrect Message
2019-01-23 Malfunction None Appropriate Term/Code Not Available
2019-01-22 Malfunction None Failure to Power Up
2019-01-22 Malfunction None Output Problem
2019-01-22 Malfunction None Moisture Damage, Device Displays Incorrect Message
2019-01-22 Malfunction None Charging Problem
2019-01-21 Malfunction None Device Displays Incorrect Message
2019-01-21 Malfunction None Device Displays Incorrect Message
2019-01-20 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-01-19 Malfunction None Display or Visual Feedback Problem, Reset Problem
2019-01-18 Malfunction None Leak/Splash, Device Displays Incorrect Message
2019-01-17 Malfunction None Battery Problem
2019-01-17 Injury None Display or Visual Feedback Problem
2019-01-17 Malfunction None Erratic or Intermittent Display
2019-01-16 Malfunction None Battery Problem
2019-01-15 Malfunction None Battery Problem
2019-01-15 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2019-01-15 Malfunction None Calibration Problem
2019-01-14 Malfunction None Charging Problem
2019-01-14 Malfunction None Vibration
2019-01-14 Malfunction None Battery Problem
2019-01-14 Malfunction None Inability to Auto-Fill
2019-01-11 Malfunction None Loss of Power
2019-01-10 Malfunction None Failure to Power Up
2019-01-10 Malfunction None Leak/Splash
2019-01-09 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-01-08 Malfunction None Battery Problem
2019-01-08 Malfunction None Break, Display or Visual Feedback Problem
2019-01-07 Malfunction None Defective Component
2019-01-07 Malfunction None Appropriate Term/Code Not Available
2019-01-07 Malfunction None Appropriate Term/Code Not Available
2019-01-07 Malfunction None Battery Problem
2019-01-06 Malfunction None Inability to Auto-Fill
2019-01-05 Malfunction None Display or Visual Feedback Problem
2019-01-05 Malfunction None Device Displays Incorrect Message
2019-01-04 Malfunction None Battery Problem
2019-01-04 Malfunction None Device Displays Incorrect Message
2019-01-03 Malfunction None Gas/Air Leak
2019-01-02 Malfunction None Loss of Power
2019-01-01 Malfunction None Device Displays Incorrect Message
2018-12-31 Malfunction None Device Alarm System, Failure to Calibrate
2018-12-31 Malfunction None No Display/Image
2018-12-31 Malfunction None Device Displays Incorrect Message
2018-12-31 Malfunction None Appropriate Term/Code Not Available
2018-12-30 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-12-29 Malfunction None Inability to Auto-Fill
2018-12-28 Malfunction None Appropriate Term/Code Not Available
2018-12-28 Malfunction None Device Alarm System, Loss of Power
2018-12-27 Malfunction None Image Display Error/Artifact
2018-12-27 Malfunction None Device Displays Incorrect Message
2018-12-27 Malfunction None Pressure Problem
2018-12-27 Malfunction None Failure to Power Up
2018-12-27 Malfunction None Leak/Splash, Device Displays Incorrect Message
2018-12-26 Malfunction None Display or Visual Feedback Problem
2018-12-26 Malfunction None Inflation Problem
2018-12-26 Malfunction None Break
2018-12-24 Malfunction None Device Displays Incorrect Message
2018-12-24 Malfunction None No Display/Image
2018-12-21 Malfunction None No Display/Image
2018-12-21 Malfunction None Improper or Incorrect Procedure or Method
2018-12-21 Malfunction None Failure to Back-Up, Loose or Intermittent Connection
2018-12-20 Malfunction None Loss of Power
2018-12-20 Malfunction None Device Displays Incorrect Message
2018-12-20 Malfunction None Appropriate Term/Code Not Available
2018-12-19 Malfunction None No Display/Image, Manufacturing, Packaging or Shipping Problem
2018-12-19 Malfunction None Failure of Device to Self-Test
2018-12-18 Malfunction None No Display/Image, Unable to Obtain Readings
2018-12-18 Malfunction None Display or Visual Feedback Problem
2018-12-18 Malfunction None Display or Visual Feedback Problem
2018-12-17 Malfunction None Unable to Obtain Readings
2018-12-17 Malfunction None Device Displays Incorrect Message
2018-12-17 Malfunction None Display or Visual Feedback Problem
2018-12-17 Malfunction None Charging Problem
2018-12-17 Malfunction None Image Display Error/Artifact
2018-12-15 Malfunction None Device Displays Incorrect Message
2018-12-14 Malfunction None Device Displays Incorrect Message
2018-12-14 Malfunction None Loss of Power, Manufacturing, Packaging or Shipping Problem
2018-12-13 Malfunction None Inability to Auto-Fill
2018-12-12 Malfunction None Loss of Power
2018-12-12 Malfunction None Device Displays Incorrect Message
2018-12-12 Malfunction None Electrical /Electronic Property Problem, Filling Problem
2018-12-12 Malfunction None Display or Visual Feedback Problem
2018-12-11 Malfunction None Electrical /Electronic Property Problem
2018-12-11 Malfunction None Device Displays Incorrect Message
2018-12-11 Malfunction None Charging Problem
2018-12-11 Malfunction None Failure to Charge
2018-12-10 Malfunction None Mechanical Problem, Date/Time-Related Software Problem
2018-12-10 Malfunction None Display or Visual Feedback Problem
2018-12-10 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-12-10 Malfunction None Display or Visual Feedback Problem
2018-12-10 Malfunction None Crack, Naturally Worn
2018-12-10 Malfunction None Component Missing
2018-12-08 Malfunction None Display or Visual Feedback Problem
2018-12-08 Malfunction None Electrical /Electronic Property Problem
2018-12-08 Malfunction None Mechanical Problem
2018-12-08 Malfunction None Inability to Auto-Fill
2018-12-07 Malfunction None Appropriate Term/Code Not Available
2018-12-06 Malfunction None Defective Device
2018-12-06 Malfunction None Battery Problem
2018-12-06 Malfunction None Failure to Calibrate
2018-12-06 Malfunction None Device Displays Incorrect Message
2018-12-05 Malfunction None Calibration Problem
2018-12-05 Malfunction None Failure to Power Up
2018-12-05 Malfunction None Battery Problem
2018-12-05 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-12-05 Malfunction None Inability to Auto-Fill
2018-12-05 Malfunction None Operating System Becomes Nonfunctional
2018-12-04 Malfunction None Leak/Splash
2018-12-04 Malfunction None Loss of Power
2018-12-03 Malfunction None No Display/Image, Failure to Power Up
2018-12-03 Malfunction None No Display/Image
2018-12-02 Malfunction None Failure of Device to Self-Test
2018-12-02 Malfunction None Erratic or Intermittent Display
2018-12-01 Malfunction None Device Displays Incorrect Message
2018-11-30 Malfunction None Break
2018-11-29 Malfunction None Inability to Auto-Fill
2018-11-29 Injury None Premature Discharge of Battery
2018-11-29 Malfunction None Loss of Power, Unexpected Shutdown
2018-11-29 Malfunction None Display or Visual Feedback Problem
2018-11-29 Malfunction None Inflation Problem, Difficult to Insert
2018-11-28 Malfunction None Display or Visual Feedback Problem
2018-11-28 Malfunction None Defective Component
2018-11-28 Malfunction None Battery Problem, Power Problem
2018-11-27 Malfunction None Display or Visual Feedback Problem
2018-11-27 Malfunction None No Display/Image
2018-11-27 Malfunction None Failure of Device to Self-Test
2018-11-27 Malfunction None No Display/Image
2018-11-27 Malfunction None Break
2018-11-27 Malfunction None Inability to Auto-Fill
2018-11-27 Malfunction None Device Displays Incorrect Message
2018-11-26 Malfunction None Battery Problem
2018-11-26 Malfunction None Gas/Air Leak
2018-11-26 Malfunction None Appropriate Term/Code Not Available
2018-11-26 Malfunction None Inability to Auto-Fill, Leak/Splash
2018-11-26 Malfunction None No Display/Image
2018-11-26 Malfunction None Erratic or Intermittent Display
2018-11-26 Malfunction None Disconnection
2018-11-23 Malfunction None Insufficient Information
2018-11-23 Malfunction None Failure to Calibrate
2018-11-23 Malfunction None Display or Visual Feedback Problem, Gas/Air Leak
2018-11-22 Malfunction None Lack of Maintenance Documentation or Guidelines
2018-11-20 Malfunction None Calibration Problem
2018-11-20 Injury None Backflow, Fluid/Blood Leak, Off-Label Use
2018-11-20 Malfunction None Communication or Transmission Problem
2018-11-19 Malfunction None Failure to Calibrate
2018-11-17 Malfunction None Leak/Splash
2018-11-16 Malfunction None Display or Visual Feedback Problem
2018-11-16 Death None Failure to Zero, High Test Results
2018-11-16 Malfunction None Fail-Safe Problem
2018-11-15 Malfunction None Display or Visual Feedback Problem, Failure to Power Up
2018-11-14 Malfunction None Date/Time-Related Software Problem
2018-11-14 Malfunction None Display or Visual Feedback Problem
2018-11-14 Malfunction None Display or Visual Feedback Problem
2018-11-14 Malfunction None No Display/Image
2018-11-13 Malfunction None Device Displays Incorrect Message
2018-11-12 Malfunction None Display or Visual Feedback Problem
2018-11-12 Malfunction None Display or Visual Feedback Problem
2018-11-11 Malfunction None Loss of Power
2018-11-11 Malfunction None Charging Problem
2018-11-09 Malfunction None Appropriate Term/Code Not Available
2018-11-09 Malfunction None Display or Visual Feedback Problem
2018-11-09 Malfunction None Communication or Transmission Problem
2018-11-09 Malfunction None Communication or Transmission Problem
2018-11-08 Malfunction None No Display/Image
2018-11-08 Malfunction None Appropriate Term/Code Not Available
2018-11-08 Malfunction None Circuit Failure
2018-11-08 Malfunction None Device Displays Incorrect Message
2018-11-08 Malfunction None No Display/Image
2018-11-07 Malfunction None Battery Problem
2018-11-07 Malfunction None Device Displays Incorrect Message
2018-11-07 Malfunction None No Display/Image
2018-11-07 Malfunction None Inability to Auto-Fill
2018-11-06 Malfunction None Defective Device
2018-11-06 Malfunction None Display or Visual Feedback Problem, Pumping Stopped
2018-11-06 Malfunction None Display or Visual Feedback Problem
2018-11-05 Malfunction None Defective Component
2018-11-05 Malfunction None Computer Operating System Problem
2018-11-05 Malfunction None Inability to Auto-Fill
2018-11-05 Malfunction None Loss of Power
2018-11-05 Malfunction None Display or Visual Feedback Problem
2018-11-05 Malfunction None Physical Resistance/Sticking
2018-11-05 Malfunction None Battery Problem
2018-11-04 Malfunction None Display or Visual Feedback Problem, Loss of Power, Appropriate Term/Code Not Available
2018-11-02 Malfunction None Output Problem
2018-11-02 Malfunction None Electrical /Electronic Property Problem
2018-11-02 Malfunction None No Display/Image
2018-11-02 Malfunction None Device Displays Incorrect Message
2018-11-01 Malfunction None Defective Component
2018-11-01 Malfunction None No Display/Image
2018-11-01 Malfunction None Device Displays Incorrect Message
2018-11-01 Malfunction None Appropriate Term/Code Not Available
2018-10-31 Malfunction None Image Display Error/Artifact
2018-10-31 Malfunction None Device Displays Incorrect Message
2018-10-31 Malfunction None Appropriate Term/Code Not Available
2018-10-30 Malfunction None Appropriate Term/Code Not Available
2018-10-30 Malfunction None Poor Quality Image
2018-10-30 Malfunction None Appropriate Term/Code Not Available
2018-10-30 Malfunction None Device Markings/Labelling Problem
2018-10-29 Malfunction None Appropriate Term/Code Not Available
2018-10-29 Malfunction None Device Displays Incorrect Message
2018-10-29 Malfunction None Noise, Audible
2018-10-29 Malfunction None Loose or Intermittent Connection, Device Displays Incorrect Message
2018-10-29 Malfunction None Battery Problem
2018-10-29 Malfunction None Display or Visual Feedback Problem
2018-10-29 Malfunction None Loose or Intermittent Connection
2018-10-28 Malfunction None Failure to Power Up
2018-10-28 Malfunction None Device Displays Incorrect Message
2018-10-26 Malfunction None Image Display Error/Artifact
2018-10-24 Malfunction None Problem with Software Installation
2018-10-24 Malfunction None Display or Visual Feedback Problem, Moisture or Humidity Problem
2018-10-24 Malfunction None Appropriate Term/Code Not Available
2018-10-24 Malfunction None Decrease in Pressure, Gas/Air Leak
2018-10-23 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-10-23 Malfunction None Device Displays Incorrect Message
2018-10-23 Malfunction None Appropriate Term/Code Not Available
2018-10-23 Malfunction None Loss of Power
2018-10-23 Malfunction None Output below Specifications
2018-10-22 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2018-10-22 Malfunction None Display or Visual Feedback Problem
2018-10-22 Malfunction None Break
2018-10-22 Malfunction None No Display/Image
2018-10-19 Malfunction None Failure to Power Up
2018-10-19 Malfunction None Inability to Auto-Fill
2018-10-19 Malfunction None Display or Visual Feedback Problem
2018-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-19 Malfunction None Device Displays Incorrect Message
2018-10-19 Malfunction None Failure to Pump
2018-10-17 Malfunction None Image Display Error/Artifact
2018-10-17 Malfunction None Break
2018-10-17 Malfunction None Display or Visual Feedback Problem
2018-10-16 Malfunction None Device Displays Incorrect Message
2018-10-16 Malfunction None Device Displays Incorrect Message
2018-10-15 Malfunction None Mechanical Problem
2018-10-15 Malfunction None Electrical /Electronic Property Problem
2018-10-15 Malfunction None Display or Visual Feedback Problem
2018-10-15 Malfunction None Output above Specifications
2018-10-15 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-10-14 Malfunction None Leak/Splash
2018-10-13 Malfunction None Display or Visual Feedback Problem, Appropriate Term/Code Not Available
2018-10-12 Malfunction None Image Display Error/Artifact
2018-10-12 Malfunction None Erratic or Intermittent Display
2018-10-11 Malfunction None Battery Problem
2018-10-11 Malfunction None Defective Device
2018-10-11 Malfunction None Appropriate Term/Code Not Available
2018-10-10 Malfunction None Unable to Obtain Readings, Incorrect, Inadequate or Imprecise Result or Readings
2018-10-10 Malfunction None Device Displays Incorrect Message
2018-10-10 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-10-10 Malfunction None Gas/Air Leak
2018-10-09 Malfunction None Complete Blockage
2018-10-09 Malfunction None Display or Visual Feedback Problem
2018-10-09 Malfunction None Appropriate Term/Code Not Available
2018-10-08 Malfunction None Device Alarm System
2018-10-08 Malfunction None Device Alarm System
2018-10-06 Death None Material Rupture
2018-10-05 Malfunction None Device Displays Incorrect Message
2018-10-05 Malfunction None Device Displays Incorrect Message
2018-10-05 Malfunction None Loss of Power, Failure to Power Up, Failure to Reset
2018-10-05 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-10-05 Malfunction None Device Damaged Prior to Use, Device Displays Incorrect Message
2018-10-04 Malfunction None Display or Visual Feedback Problem
2018-10-04 Malfunction None Battery Problem
2018-10-03 Injury None Material Rupture
2018-10-03 Malfunction None Battery Problem
2018-10-03 Malfunction None Failure to Calibrate
2018-10-03 Malfunction None Loss of Power
2018-10-03 Malfunction None Failure to Read Input Signal
2018-10-03 Malfunction None Protective Measures Problem
2018-10-02 Malfunction None Device Displays Incorrect Message
2018-10-02 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-10-02 Malfunction None Appropriate Term/Code Not Available
2018-10-01 Malfunction None Break, Appropriate Term/Code Not Available
2018-10-01 Malfunction None Device Displays Incorrect Message
2018-10-01 Malfunction None Noise, Audible
2018-09-28 Malfunction None Loss of Power
2018-09-28 Malfunction None Failure to Power Up
2018-09-28 Malfunction None Device Displays Incorrect Message
2018-09-28 Malfunction None Failure to Charge
2018-09-28 Malfunction None Display or Visual Feedback Problem
2018-09-27 Malfunction None Unexpected Shutdown
2018-09-27 Malfunction None Display or Visual Feedback Problem
2018-09-27 Malfunction None Failure to Calibrate
2018-09-27 Malfunction None Inability to Auto-Fill
2018-09-27 Malfunction None Device Displays Incorrect Message
2018-09-27 Malfunction None No Display/Image
2018-09-27 Malfunction None Appropriate Term/Code Not Available
2018-09-27 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-09-27 Malfunction None Battery Problem
2018-09-27 Malfunction None Device Displays Incorrect Message, Therapeutic or Diagnostic Output Failure
2018-09-27 Malfunction None Device Displays Incorrect Message, Connection Problem
2018-09-26 Malfunction None Leak/Splash
2018-09-26 Malfunction None Power Problem
2018-09-26 Malfunction None Insufficient Information
2018-09-26 Malfunction None Inflation Problem
2018-09-26 Malfunction None Battery Problem
2018-09-26 Malfunction None Protective Measures Problem
2018-09-26 Malfunction None Display or Visual Feedback Problem
2018-09-25 Malfunction None Defective Device
2018-09-25 Malfunction None Gas/Air Leak, Material Split, Cut or Torn
2018-09-25 Malfunction None Loss of Power
2018-09-25 Malfunction None Battery Problem, Output Problem
2018-09-25 Malfunction None Appropriate Term/Code Not Available
2018-09-25 Malfunction None Failure to Calibrate
2018-09-24 Malfunction None Charging Problem
2018-09-24 Malfunction None Device Displays Incorrect Message
2018-09-24 Malfunction None Electrical /Electronic Property Problem
2018-09-24 Malfunction None Loss of Power, Battery Problem
2018-09-23 Malfunction None Gas/Air Leak, Appropriate Term/Code Not Available
2018-09-23 Malfunction None Loss of Power, Device Displays Incorrect Message, Battery Problem
2018-09-22 Malfunction None Device Displays Incorrect Message
2018-09-21 Malfunction None Defective Device
2018-09-21 Malfunction None Inability to Auto-Fill, No Display/Image, Loss of Power
2018-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-21 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-09-20 Malfunction None Battery Problem
2018-09-20 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-09-20 Malfunction None Calibration Problem
2018-09-20 Malfunction None Output Problem
2018-09-20 Malfunction None Defective Component
2018-09-20 Malfunction None Defective Device
2018-09-19 Malfunction None No Display/Image
2018-09-19 Malfunction None Premature Discharge of Battery, Loss of Power, Device Damaged Prior to Use
2018-09-19 Malfunction None Display or Visual Feedback Problem
2018-09-18 Malfunction None Device Displays Incorrect Message, Gas/Air Leak, Noise, Audible
2018-09-18 Malfunction None Battery Problem
2018-09-18 Malfunction None Defective Device
2018-09-17 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-09-17 Malfunction None Appropriate Term/Code Not Available
2018-09-17 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-09-17 Malfunction None Appropriate Term/Code Not Available
2018-09-17 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-09-17 Malfunction None No Display/Image
2018-09-15 Malfunction None Device Displays Incorrect Message
2018-09-15 Malfunction None Device Alarm System, Inability to Auto-Fill, Loss of Power, Failure to Reset, Unexpected Shutdown
2018-09-14 Malfunction None Device Displays Incorrect Message
2018-09-14 Malfunction None Loss of Power, Failure to Power Up
2018-09-14 Malfunction None No Display/Image
2018-09-14 Malfunction None Self-Activation or Keying
2018-09-13 Malfunction None Failure of Device to Self-Test
2018-09-13 Malfunction None No Display/Image, Failure to Power Up, Noise, Audible
2018-09-12 Malfunction None Appropriate Term/Code Not Available
2018-09-12 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-09-12 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-09-12 Injury None Failure to Calibrate, Device Displays Incorrect Message
2018-09-12 Malfunction None Device Displays Incorrect Message
2018-09-10 Malfunction None No Display/Image, Electrical /Electronic Property Problem
2018-09-10 Malfunction None Device Displays Incorrect Message, Calibration Problem
2018-09-10 Malfunction None Battery Problem
2018-09-10 Malfunction None Battery Problem
2018-09-10 Malfunction None Device Displays Incorrect Message
2018-09-10 Malfunction None Battery Problem
2018-09-07 Malfunction None No Display/Image, Noise, Audible
2018-09-07 Malfunction None Failure of Device to Self-Test
2018-09-07 Malfunction None Device Displays Incorrect Message
2018-09-07 Malfunction None Device Displays Incorrect Message
2018-09-07 Malfunction None Loss of Power, Failure to Power Up
2018-09-07 Malfunction None Battery Problem
2018-09-06 Malfunction None Failure to Power Up
2018-09-06 Malfunction None Device Displays Incorrect Message
2018-09-06 Malfunction None No Display/Image
2018-09-06 Malfunction None Failure to Power Up
2018-09-05 Malfunction None Loss of Power
2018-09-05 Malfunction None No Display/Image
2018-09-05 Malfunction None Defective Component
2018-09-05 Malfunction None Battery Problem
2018-09-05 Malfunction None Failure to Power Up
2018-09-04 Malfunction None Failure to Zero
2018-09-04 Malfunction None No Display/Image
2018-09-04 Malfunction None Display or Visual Feedback Problem
2018-09-04 Malfunction None Battery Problem
2018-09-03 Malfunction None No Audible Alarm
2018-09-02 Malfunction None Image Display Error/Artifact
2018-09-01 Malfunction None Appropriate Term/Code Not Available
2018-08-29 Malfunction None Charging Problem
2018-08-29 Malfunction None Inability to Auto-Fill
2018-08-29 Malfunction None Failure to Read Input Signal
2018-08-28 Malfunction None Battery Problem
2018-08-27 Malfunction None Noise, Audible
2018-08-27 Malfunction None Nonstandard Device
2018-08-27 Malfunction None Appropriate Term/Code Not Available
2018-08-27 Malfunction None Optical Problem
2018-08-27 Malfunction None No Display/Image
2018-08-27 Malfunction None Disconnection
2018-08-25 Malfunction None Device Markings/Labelling Problem
2018-08-24 Malfunction None Failure to Calibrate
2018-08-24 Malfunction None Defective Device
2018-08-24 Malfunction None Decrease in Suction
2018-08-24 Malfunction None Inability to Auto-Fill
2018-08-23 Malfunction None Device Displays Incorrect Message, Calibration Problem
2018-08-23 Malfunction None Display or Visual Feedback Problem, Failure to Calibrate
2018-08-23 Malfunction None Device Displays Incorrect Message
2018-08-23 Malfunction None Failure of Device to Self-Test
2018-08-23 Malfunction None Failure of Device to Self-Test
2018-08-22 Malfunction None Failure to Power Up, Noise, Audible, Unexpected Shutdown
2018-08-22 Malfunction None Loss of Power
2018-08-22 Malfunction None Corroded, Failure to Calibrate
2018-08-22 Malfunction None Display or Visual Feedback Problem
2018-08-22 Malfunction None Loss of Power
2018-08-22 Malfunction None Component Missing
2018-08-21 Malfunction None Device Displays Incorrect Message
2018-08-21 Malfunction None Inability to Auto-Fill
2018-08-21 Malfunction None Electrical /Electronic Property Problem
2018-08-21 Malfunction None Break
2018-08-21 Malfunction None Appropriate Term/Code Not Available
2018-08-21 Malfunction None Premature Discharge of Battery, Loss of Power
2018-08-21 Malfunction None Appropriate Term/Code Not Available
2018-08-21 Malfunction None Appropriate Term/Code Not Available
2018-08-20 Malfunction None Break
2018-08-20 Malfunction None Battery Problem
2018-08-20 Malfunction None Appropriate Term/Code Not Available
2018-08-20 Malfunction None Electrical Power Problem
2018-08-20 Malfunction None Battery Problem
2018-08-20 Malfunction None Device Displays Incorrect Message
2018-08-20 Malfunction None Appropriate Term/Code Not Available
2018-08-17 Malfunction None Inability to Auto-Fill
2018-08-17 Malfunction None Gas/Air Leak
2018-08-17 Malfunction None Battery Problem
2018-08-16 Injury None No Audible Alarm, Fluid/Blood Leak, Material Rupture, Device Contamination with Body Fluid
2018-08-16 Malfunction None Material Rupture
2018-08-16 Malfunction None Display or Visual Feedback Problem
2018-08-15 Malfunction None Device Difficult to Maintain
2018-08-15 Malfunction None Electrical /Electronic Property Problem
2018-08-15 Malfunction None Battery Problem
2018-08-15 Malfunction None Battery Problem
2018-08-15 Malfunction None Defective Component
2018-08-15 Malfunction None Device Displays Incorrect Message
2018-08-15 Malfunction None Loss of Power
2018-08-15 Malfunction None Inflation Problem
2018-08-15 Malfunction None Failure to Select Signal
2018-08-14 Malfunction None False Alarm
2018-08-14 Malfunction None Defective Device
2018-08-14 Injury None Display or Visual Feedback Problem
2018-08-14 Malfunction None Device Alarm System, No Display/Image, Loss of Power
2018-08-10 Malfunction None Defective Component
2018-08-10 Malfunction None Failure to Deliver Energy
2018-08-10 Malfunction None Failure to Power Up
2018-08-10 Malfunction None Charging Problem
2018-08-09 Malfunction None Battery Problem
2018-08-09 Malfunction None Electrical /Electronic Property Problem
2018-08-09 Malfunction None Failure to Power Up
2018-08-09 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-08-09 Malfunction None Device Displays Incorrect Message
2018-08-09 Malfunction None Device Displays Incorrect Message, Inappropriate or Unexpected Reset
2018-08-09 Malfunction None Defective Component
2018-08-09 Malfunction None Data Problem
2018-08-09 Malfunction None Material Discolored
2018-08-08 Malfunction None Appropriate Term/Code Not Available
2018-08-08 Malfunction None Device Misassembled During Manufacturing /Shipping
2018-08-08 Malfunction None No Display/Image
2018-08-08 Malfunction None Noise, Audible
2018-08-07 Malfunction None Failure of Device to Self-Test
2018-08-07 Malfunction None Difficult to Remove, Appropriate Term/Code Not Available
2018-08-07 Malfunction None Display or Visual Feedback Problem
2018-08-07 Malfunction None Failure to Power Up
2018-08-06 Malfunction None Moisture or Humidity Problem
2018-08-06 Malfunction None Defective Device
2018-08-06 Malfunction None Loss of Power
2018-08-03 Malfunction None Physical Resistance/Sticking
2018-08-02 Injury None Appropriate Term/Code Not Available
2018-08-02 Malfunction None Appropriate Term/Code Not Available
2018-08-02 Malfunction None Erratic or Intermittent Display, Poor Quality Image
2018-08-01 Malfunction None Failure to Deliver
2018-08-01 Malfunction None Communication or Transmission Problem
2018-08-01 Malfunction None Intermittent Loss of Power
2018-08-01 Malfunction None Battery Problem
2018-08-01 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-08-01 Malfunction None Device Damaged Prior to Use
2018-07-31 Malfunction None Mechanical Problem, Connection Problem
2018-07-31 Malfunction None Break
2018-07-31 Malfunction None Loss of Power
2018-07-31 Malfunction None No Display/Image
2018-07-31 Malfunction None Loss of Power, Device Remains Activated
2018-07-30 Malfunction None Device Displays Incorrect Message
2018-07-30 Malfunction None Leak/Splash
2018-07-30 Malfunction None Pressure Problem
2018-07-28 Malfunction None No Display/Image
2018-07-26 Malfunction None Communication or Transmission Problem, Output Problem
2018-07-26 Malfunction None No Display/Image
2018-07-25 Malfunction None Device Displays Incorrect Message
2018-07-25 Malfunction None Electrical /Electronic Property Problem
2018-07-25 Malfunction None Decrease in Suction
2018-07-25 Malfunction None Battery Problem
2018-07-24 Malfunction None Electrical /Electronic Property Problem
2018-07-24 Malfunction None Calibration Problem
2018-07-24 Malfunction None Expiration Date Error, Battery Problem
2018-07-24 Malfunction None Device Sensing Problem
2018-07-24 Malfunction None Gas/Air Leak
2018-07-24 Malfunction None Inflation Problem
2018-07-24 Malfunction None Device Displays Incorrect Message
2018-07-23 Malfunction None Filling Problem, Leak/Splash
2018-07-23 Malfunction None Unexpected Shutdown
2018-07-23 Malfunction None Electrical /Electronic Property Problem
2018-07-23 Malfunction None Break
2018-07-23 Malfunction None Calibration Problem
2018-07-21 Malfunction None Pumping Stopped
2018-07-20 Malfunction None Material Deformation
2018-07-20 Malfunction None Device Displays Incorrect Message
2018-07-20 Malfunction None Loss of Power
2018-07-20 Malfunction None Display or Visual Feedback Problem
2018-07-19 Malfunction None No Display/Image
2018-07-19 Malfunction None Failure to Sense
2018-07-18 Malfunction None Failure to Charge
2018-07-17 Malfunction None Display or Visual Feedback Problem
2018-07-16 Malfunction None No Device Output
2018-07-16 Malfunction None Device Sensing Problem
2018-07-16 Malfunction None Output Problem
2018-07-16 Malfunction None Pressure Problem
2018-07-13 Malfunction None Defective Component, Defective Device
2018-07-13 Malfunction None Loss of Power
2018-07-13 Malfunction None Failure of Device to Self-Test
2018-07-13 Malfunction None Battery Problem, Device Fell
2018-07-13 Malfunction None Loss of Power
2018-07-12 Malfunction None Inability to Auto-Fill
2018-07-12 Malfunction None Battery Problem
2018-07-12 Malfunction None Mechanical Problem, Battery Problem
2018-07-12 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-07-11 Malfunction None Expiration Date Error
2018-07-11 Malfunction None Defective Device
2018-07-11 Malfunction None Computer Operating System Problem
2018-07-11 Malfunction None Loss of Power
2018-07-11 Malfunction None Device Displays Incorrect Message
2018-07-11 Malfunction None Power Problem
2018-07-10 Malfunction None Failure of Device to Self-Test
2018-07-10 Malfunction None Battery Problem
2018-07-10 Malfunction None Premature Discharge of Battery
2018-07-10 Malfunction None Leak/Splash
2018-07-10 Malfunction None Expiration Date Error
2018-07-10 Malfunction None Battery Problem, Failure of Device to Self-Test
2018-07-10 Malfunction None Expiration Date Error, Battery Problem, Appropriate Term/Code Not Available
2018-07-09 Malfunction None No Display/Image
2018-07-09 Malfunction None Crack
2018-07-09 Malfunction None No Display/Image, Noise, Audible
2018-07-09 Malfunction None Fail-Safe Problem
2018-07-09 Malfunction None Device Displays Incorrect Message
2018-07-08 Malfunction None Inability to Auto-Fill
2018-07-06 Malfunction None Leak/Splash
2018-07-06 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-07-06 Malfunction None Device Displays Incorrect Message
2018-07-05 Malfunction None Device Displays Incorrect Message
2018-07-04 Malfunction None Leak/Splash, Pressure Problem
2018-07-04 Malfunction None Gas/Air Leak
2018-07-03 Malfunction None Battery Problem
2018-07-03 Malfunction None Device Displays Incorrect Message
2018-07-03 Malfunction None Image Display Error/Artifact
2018-07-03 Malfunction None Leak/Splash
2018-07-02 Malfunction None Device Displays Incorrect Message
2018-07-02 Malfunction None Display or Visual Feedback Problem
2018-07-02 Malfunction None Failure of Device to Self-Test
2018-07-02 Malfunction None Failure of Device to Self-Test
2018-07-02 Malfunction None Loss of Power
2018-06-30 Malfunction None Device Displays Incorrect Message
2018-06-29 Malfunction None Device Damaged Prior to Use, Device Displays Incorrect Message
2018-06-29 Malfunction None Break, Loose or Intermittent Connection
2018-06-29 Malfunction None Mechanical Problem
2018-06-29 Malfunction None Display or Visual Feedback Problem
2018-06-28 Malfunction None No Display/Image
2018-06-28 Malfunction None Device Displays Incorrect Message
2018-06-27 Malfunction None Device Displays Incorrect Message
2018-06-27 Malfunction None Failure of Device to Self-Test
2018-06-27 Malfunction None Deflation Problem, Inflation Problem
2018-06-27 Malfunction None Display or Visual Feedback Problem
2018-06-27 Malfunction None No Display/Image
2018-06-27 Malfunction None Pressure Problem
2018-06-27 Malfunction None Electrical /Electronic Property Problem
2018-06-27 Malfunction None Defective Alarm
2018-06-26 Malfunction None Battery Problem
2018-06-25 Malfunction None Gas/Air Leak
2018-06-25 Malfunction None Leak/Splash
2018-06-25 Malfunction None Inability to Auto-Fill
2018-06-25 Death None Device Inoperable
2018-06-25 Malfunction None Device Operates Differently Than Expected
2018-06-24 Malfunction None Device Displays Incorrect Message, Device Sensing Problem, Data Problem
2018-06-23 Malfunction None No Display/Image, Loss of Power
2018-06-22 Malfunction None Erratic or Intermittent Display
2018-06-22 Malfunction None Calibration Problem
2018-06-21 Malfunction None Device Displays Incorrect Message
2018-06-21 Malfunction None Calibration Problem, Pressure Problem
2018-06-21 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings
2018-06-20 Malfunction None Display or Visual Feedback Problem
2018-06-20 Malfunction None Material Rupture
2018-06-20 Malfunction None Device Displays Incorrect Message
2018-06-19 Malfunction None Inflation Problem
2018-06-19 Malfunction None Crack, Device Inoperable
2018-06-19 Malfunction None Failure to Run on Battery
2018-06-18 Malfunction None No Apparent Adverse Event
2018-06-18 Malfunction None Computer Software Problem
2018-06-18 Malfunction None Appropriate Term/Code Not Available
2018-06-18 Malfunction None Mechanical Problem
2018-06-18 Malfunction None Gas/Air Leak
2018-06-17 Malfunction None No Display/Image, Loss of Power
2018-06-17 Malfunction None No Pressure
2018-06-17 Malfunction None Loss of Power
2018-06-17 Malfunction None No Display/Image, Loss of Power
2018-06-17 Malfunction None Loss of Power
2018-06-17 Malfunction None Appropriate Term/Code Not Available
2018-06-16 Malfunction None Loss of Power
2018-06-15 Malfunction None Optical Problem
2018-06-15 Malfunction None Device Alarm System, Device Displays Incorrect Message
2018-06-15 Malfunction None Device Displays Incorrect Message
2018-06-14 Malfunction None Battery Problem
2018-06-14 Malfunction None Loss of Power
2018-06-14 Malfunction None Device Displays Incorrect Message
2018-06-14 Malfunction None Battery Problem
2018-06-14 Malfunction None Defective Component
2018-06-13 Malfunction None No Display/Image
2018-06-13 Malfunction None Failure to Calibrate
2018-06-13 Malfunction None Leak/Splash, Failure of Device to Self-Test
2018-06-13 Malfunction None Battery Problem
2018-06-13 Malfunction None Premature Discharge of Battery
2018-06-12 Malfunction None Device Displays Incorrect Message
2018-06-12 Malfunction None No Display/Image
2018-06-12 Malfunction None No Display/Image
2018-06-11 Malfunction None Lack of Maintenance Documentation or Guidelines
2018-06-11 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-06-11 Malfunction None Device Displays Incorrect Message
2018-06-10 Malfunction None Device Displays Incorrect Message
2018-06-08 Malfunction None Device Displays Incorrect Message
2018-06-08 Malfunction None Failure to Read Input Signal
2018-06-07 Malfunction None Device Inoperable, Defective Component
2018-06-07 Malfunction None Failure to Charge
2018-06-06 Malfunction None Device Contamination with Body Fluid, Device Displays Incorrect Message
2018-06-06 Malfunction None Device Displays Incorrect Message
2018-06-06 Malfunction None Device Inoperable
2018-06-06 Malfunction None Device Markings/Labelling Problem
2018-06-06 Malfunction None No Display/Image, Device Displays Incorrect Message
2018-06-05 Malfunction None Erratic or Intermittent Display
2018-06-05 Malfunction None Battery Problem
2018-06-05 Malfunction None No Display/Image
2018-06-05 Malfunction None Expiration Date Error, Device Displays Incorrect Message, Battery Problem
2018-06-04 Malfunction None Device Displays Incorrect Message
2018-06-01 Malfunction None Failure of Device to Self-Test
2018-05-31 Malfunction None No Display/Image
2018-05-30 Malfunction None Device Displays Incorrect Message
2018-05-30 Malfunction None Inadequate Lighting
2018-05-30 Malfunction None Device Displays Incorrect Message
2018-05-30 Malfunction None Device Displays Incorrect Message
2018-05-30 Malfunction None Device Operates Differently Than Expected
2018-05-29 Malfunction None Battery Problem
2018-05-29 Malfunction None Device Operates Differently Than Expected
2018-05-29 Malfunction None Premature Discharge of Battery
2018-05-27 Malfunction None Loss of Power
2018-05-25 Malfunction None Battery Problem
2018-05-25 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2018-05-25 Malfunction None No Display/Image
2018-05-25 Malfunction None No Display/Image
2018-05-25 Malfunction None Device Operates Differently Than Expected, Mechanical Jam
2018-05-25 Malfunction None Device Displays Incorrect Message
2018-05-25 Malfunction None No Display/Image, Failure to Power Up, Device Displays Incorrect Message
2018-05-24 Malfunction None Device Displays Incorrect Message
2018-05-23 Malfunction None Device Operates Differently Than Expected
2018-05-23 Malfunction None Leak/Splash, Device Damaged Prior to Use
2018-05-23 Malfunction None Image Display Error/Artifact
2018-05-22 Malfunction None Device Displays Incorrect Message
2018-05-22 Malfunction None Loss of Power, Device Inoperable, Device Displays Incorrect Message
2018-05-22 Malfunction None Device Displays Incorrect Message
2018-05-21 Malfunction None Failure to Charge
2018-05-21 Malfunction None Break
2018-05-21 Malfunction None Break
2018-05-21 Malfunction None No Display/Image, Pumping Stopped
2018-05-21 Malfunction None Device Displays Incorrect Message
2018-05-21 Malfunction None Device Displays Incorrect Message
2018-05-18 Malfunction None Fitting Problem, Device Displays Incorrect Message
2018-05-17 Malfunction None Pressure Problem
2018-05-17 Malfunction None Device Displays Incorrect Message
2018-05-17 Malfunction None Inability to Auto-Fill, Disconnection
2018-05-17 Malfunction None Insufficient Information
2018-05-17 Malfunction None Device Displays Incorrect Message
2018-05-16 Malfunction None Device Operates Differently Than Expected
2018-05-16 Malfunction None Device Displays Incorrect Message
2018-05-16 Malfunction None Battery Problem
2018-05-16 Malfunction None Battery Problem
2018-05-16 Malfunction None Device Operates Differently Than Expected
2018-05-16 Malfunction None Battery Problem
2018-05-16 Malfunction None Failure to Calibrate
2018-05-16 Malfunction None Battery Problem
2018-05-16 Malfunction None Battery Problem
2018-05-16 Malfunction None Misassembled, Failure to Power Up, Device Displays Incorrect Message
2018-05-16 Malfunction None Low Battery
2018-05-15 Malfunction None Battery Problem
2018-05-15 Malfunction None Incorrect Or Inadequate Test Results
2018-05-15 Malfunction None Device Displays Incorrect Message
2018-05-15 Malfunction None Failure of Device to Self-Test
2018-05-15 Malfunction None Battery Problem
2018-05-14 Malfunction None Device Displays Incorrect Message, Noise, Audible
2018-05-14 Malfunction None Device Operates Differently Than Expected
2018-05-14 Malfunction None Device Displays Incorrect Message
2018-05-11 Malfunction None Device Displays Incorrect Message
2018-05-11 Malfunction None No Display/Image
2018-05-10 Malfunction None Device Displays Incorrect Message
2018-05-10 Malfunction None Device Operates Differently Than Expected
2018-05-10 Malfunction None Pumping Stopped, Failure to Select Signal
2018-05-10 Malfunction None Device Displays Incorrect Message
2018-05-10 Malfunction None Device Displays Incorrect Message
2018-05-10 Malfunction None Device Operates Differently Than Expected
2018-05-09 Malfunction None Device Displays Incorrect Message
2018-05-09 Malfunction None Electrical /Electronic Property Problem
2018-05-09 Malfunction None Device Displays Incorrect Message
2018-05-09 Malfunction None Failure to Charge
2018-05-09 Malfunction None Device Displays Incorrect Message
2018-05-09 Malfunction None Battery Problem
2018-05-09 Malfunction None Device Operates Differently Than Expected
2018-05-09 Malfunction None Device Displays Incorrect Message, Battery Problem
2018-05-08 Malfunction None Device Displays Incorrect Message
2018-05-08 Malfunction None Failure to Charge
2018-05-08 Malfunction None Incorrect Or Inadequate Test Results
2018-05-07 Malfunction None No Display/Image
2018-05-07 Malfunction None Loss of Data
2018-05-06 Malfunction None Device Displays Incorrect Message
2018-05-06 Malfunction None Device Displays Incorrect Message
2018-05-05 Malfunction None Device Displays Incorrect Message
2018-05-04 Malfunction None Device Displays Incorrect Message
2018-05-03 Malfunction None Device Displays Incorrect Message
2018-05-03 Malfunction None Failure to Power Up
2018-05-03 Death None Device Displays Incorrect Message, Device Sensing Problem
2018-05-03 Malfunction None Failure to Power Up, Inadequate Lighting
2018-05-03 Malfunction None Device Operates Differently Than Expected
2018-05-02 Malfunction None Device Displays Incorrect Message
2018-05-02 Malfunction None Inability to Auto-Fill
2018-04-30 Malfunction None Device Displays Incorrect Message
2018-04-27 Malfunction None Battery Problem
2018-04-26 Malfunction None Device Operates Differently Than Expected
2018-04-26 Malfunction None Device Operates Differently Than Expected
2018-04-26 Malfunction None Battery Problem
2018-04-25 Malfunction None Device Operates Differently Than Expected
2018-04-25 Malfunction None Device Displays Incorrect Message
2018-04-25 Malfunction None Device Operates Differently Than Expected
2018-04-25 Injury None Device Displays Incorrect Message
2018-04-25 Malfunction None Device Operates Differently Than Expected
2018-04-24 Malfunction None Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem
2018-04-24 Malfunction None Battery Problem
2018-04-24 Malfunction None Break
2018-04-24 Malfunction None Inability to Auto-Fill
2018-04-22 Malfunction None Device Contamination with Body Fluid, Device Operates Differently Than Expected
2018-04-21 Malfunction None Device Operates Differently Than Expected
2018-04-20 Malfunction None Device Operates Differently Than Expected
2018-04-20 Malfunction None Device Displays Incorrect Message
2018-04-20 Malfunction None Device Displays Incorrect Message
2018-04-19 Malfunction None Device Displays Incorrect Message
2018-04-19 Malfunction None Break
2018-04-19 Malfunction None Device Displays Incorrect Message
2018-04-18 Malfunction None Device Displays Incorrect Message
2018-04-18 Malfunction None No Display/Image
2018-04-17 Malfunction None Loss of Power
2018-04-17 Malfunction None Break
2018-04-17 Malfunction None Device Alarm System, Loss of Power
2018-04-17 Malfunction None Display or Visual Feedback Problem
2018-04-16 Malfunction None Leak/Splash, Device Displays Incorrect Message
2018-04-16 Malfunction None Inability to Auto-Fill
2018-04-16 Malfunction None Device Operates Differently Than Expected
2018-04-16 Malfunction None Device Displays Incorrect Message
2018-04-16 Malfunction None Inability to Auto-Fill
2018-04-16 Malfunction None Battery Problem
2018-04-16 Malfunction None Incorrect Or Inadequate Test Results
2018-04-16 Malfunction None Device Operates Differently Than Expected
2018-04-15 Malfunction None Device Displays Incorrect Message
2018-04-13 Malfunction None Device Operates Differently Than Expected
2018-04-13 Malfunction None Break
2018-04-13 Malfunction None Failure to Charge
2018-04-13 Malfunction None Device Stops Intermittently, Device Displays Incorrect Message
2018-04-12 Malfunction None Suction Problem
2018-04-12 Malfunction None Device Inoperable
2018-04-12 Malfunction None Battery Problem
2018-04-12 Malfunction None Device Maintenance Issue, Device Operates Differently Than Expected
2018-04-12 Malfunction None Device Displays Incorrect Message
2018-04-11 Malfunction None Device Operates Differently Than Expected
2018-04-11 Malfunction None Device Operates Differently Than Expected
2018-04-11 Malfunction None Failure of Device to Self-Test
2018-04-10 Malfunction None Device Displays Incorrect Message
2018-04-10 Malfunction None Inability to Auto-Fill
2018-04-10 Malfunction None Inability to Auto-Fill, Device Displays Incorrect Message
2018-04-10 Malfunction None Failure to Charge, Loss of Power
2018-04-10 Malfunction None Device Displays Incorrect Message
2018-04-10 Malfunction None Device Displays Incorrect Message
2018-04-09 Malfunction None Device Displays Incorrect Message
2018-04-09 Malfunction None Battery Problem, Device Operates Differently Than Expected
2018-04-07 Malfunction None Low Battery, Device Displays Incorrect Message
2018-04-07 Malfunction None Device Displays Incorrect Message
2018-04-05 Malfunction None Device Displays Incorrect Message
2018-04-05 Malfunction None Device Displays Incorrect Message
2018-04-05 Malfunction None Loss of Power
2018-04-05 Malfunction None Device Displays Incorrect Message
2018-04-03 Malfunction None Device Displays Incorrect Message
2018-04-03 Malfunction None Device Displays Incorrect Message
2018-04-03 Malfunction None Device Operates Differently Than Expected, Failure of Device to Self-Test
2018-04-02 Malfunction None Device Operates Differently Than Expected
2018-04-02 Malfunction None Maintenance Does Not Comply To Manufacturers Recommendations
2018-04-02 Malfunction None Electronic Property Issue
2018-04-02 Malfunction None Leak/Splash
2018-03-31 Malfunction None Device Displays Incorrect Message
2018-03-30 Malfunction None Calibration Problem
2018-03-29 Death None Material Rupture, Device Displays Incorrect Message
2018-03-29 Malfunction None Device Operates Differently Than Expected
2018-03-28 Malfunction None Incorrect Or Inadequate Test Results
2018-03-28 Malfunction None Leak/Splash, Device Operates Differently Than Expected
2018-03-28 Malfunction None Device Operates Differently Than Expected
2018-03-28 Malfunction None Incorrect Or Inadequate Test Results, Device Displays Incorrect Message
2018-03-28 Malfunction None Device Displays Incorrect Message
2018-03-27 Malfunction None Device Displays Incorrect Message
2018-03-27 Malfunction None Device Displays Incorrect Message
2018-03-27 Malfunction None Device Operates Differently Than Expected
2018-03-26 Malfunction None Image Display Error/Artifact
2018-03-26 Malfunction None Device Displays Incorrect Message
2018-03-26 Malfunction None Erratic or Intermittent Display, Device Operates Differently Than Expected
2018-03-26 Malfunction None Device Emits Odor
2018-03-26 Malfunction None Device Operates Differently Than Expected
2018-03-26 Malfunction None Device Operates Differently Than Expected
2018-03-26 Malfunction None Device Operates Differently Than Expected
2018-03-26 Malfunction None Device Operates Differently Than Expected
2018-03-24 Malfunction None No Display/Image
2018-03-24 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2018-03-24 Malfunction None Device Stops Intermittently
2018-03-23 Malfunction None Device Displays Incorrect Message
2018-03-23 Malfunction None Application Program Problem
2018-03-23 Malfunction None Image Display Error/Artifact
2018-03-23 Malfunction None Disconnection, Device Displays Incorrect Message
2018-03-23 Malfunction None Disconnection, Device Displays Incorrect Message
2018-03-23 Malfunction None Device Displays Incorrect Message
2018-03-23 Malfunction None Device Operates Differently Than Expected, Operating System Becomes Nonfunctional
2018-03-23 Malfunction None Device Operates Differently Than Expected
2018-03-22 Malfunction None Incorrect Or Inadequate Test Results
2018-03-22 Malfunction None Device Displays Incorrect Message
2018-03-22 Malfunction None Device Inoperable
2018-03-22 Malfunction None Incorrect Or Inadequate Test Results
2018-03-21 Death None Device Displays Incorrect Message
2018-03-21 Malfunction None Deflation Problem
2018-03-21 Malfunction None Device Operates Differently Than Expected
2018-03-20 Malfunction None Device Displays Incorrect Message
2018-03-20 Malfunction None Noise, Audible
2018-03-20 Malfunction None Device Operates Differently Than Expected
2018-03-20 Malfunction None Battery Problem
2018-03-20 Malfunction None Defective Component, Device Operates Differently Than Expected
2018-03-20 Malfunction None Device Operates Differently Than Expected
2018-03-19 Malfunction None Image Display Error/Artifact
2018-03-19 Malfunction None Incorrect Or Inadequate Test Results
2018-03-19 Malfunction None Inflation Problem
2018-03-19 Malfunction None Battery Problem
2018-03-18 Malfunction None Power Conditioning Problem
2018-03-16 Malfunction None Loss of Power
2018-03-16 Malfunction None Leak/Splash
2018-03-15 Malfunction None Device Displays Incorrect Message, Gas/Air Leak
2018-03-15 Malfunction None Pumping Stopped, Device Displays Incorrect Message
2018-03-14 Malfunction None Device Displays Incorrect Message
2018-03-14 Malfunction None Device Displays Incorrect Message
2018-03-14 Malfunction None Device Operates Differently Than Expected
2018-03-13 Malfunction None Device Displays Incorrect Message
2018-03-13 Malfunction None Inability to Auto-Fill
2018-03-12 Malfunction None Device Displays Incorrect Message
2018-03-12 Malfunction None Device Operates Differently Than Expected
2018-03-12 Malfunction None Battery Problem
2018-03-09 Death None Improper Flow or Infusion
2018-03-09 Malfunction None Device Operates Differently Than Expected
2018-03-09 Malfunction None Fluid/Blood Leak, Device Displays Incorrect Message
2018-03-08 Malfunction None Display or Visual Feedback Problem
2018-03-08 Malfunction None Device Alarm System, Loss of Power
2018-03-08 Malfunction None Failure to Read Input Signal
2018-03-08 Malfunction None Premature Discharge of Battery
2018-03-07 Malfunction None Device Operates Differently Than Expected
2018-03-07 Malfunction None Battery Problem
2018-03-07 Malfunction None Device Displays Incorrect Message
2018-03-06 Malfunction None Device Operates Differently Than Expected
2018-03-06 Malfunction None Device Operates Differently Than Expected
2018-03-06 Malfunction None Gas/Air Leak
2018-03-06 Malfunction None Defective Component
2018-03-06 Malfunction None Loss of Power, Self-Activation or Keying
2018-03-06 Malfunction None Smoking
2018-03-06 Malfunction None Device Displays Incorrect Message
2018-03-06 Malfunction None Inability to Auto-Fill, Pumping Stopped
2018-03-06 Malfunction None Battery Problem
2018-03-06 Malfunction None Inability to Auto-Fill, Disconnection
2018-03-06 Malfunction None Device Operates Differently Than Expected
2018-03-06 Malfunction None Charging Problem
2018-03-05 Malfunction None Device Displays Incorrect Message
2018-03-05 Malfunction None Device Displays Incorrect Message
2018-03-05 Malfunction None Device Expiration Issue, Leak/Splash, Device Maintenance Issue
2018-03-02 Malfunction None Failure to Power Up
2018-03-02 Malfunction None Device Operates Differently Than Expected
2018-03-02 Malfunction None Device Operates Differently Than Expected
2018-03-01 Malfunction None Pressure Problem
2018-03-01 Malfunction None Loss of Power
2018-03-01 Malfunction None Device Displays Incorrect Message
2018-03-01 Malfunction None Unable to Obtain Readings
2018-03-01 Malfunction None Gas Output Problem, Device Displays Incorrect Message
2018-03-01 Malfunction None Break
2018-02-28 Malfunction None Device Displays Incorrect Message
2018-02-28 Malfunction None Device Displays Incorrect Message
2018-02-28 Malfunction None Device Displays Incorrect Message
2018-02-28 Malfunction None Computer Software Problem
2018-02-28 Malfunction None Nonstandard Device, Computer Operating System Problem
2018-02-27 Malfunction None Device Displays Incorrect Message
2018-02-27 Malfunction None Device Displays Incorrect Message
2018-02-27 Malfunction None Backflow, Loss of Power
2018-02-27 Malfunction None Inability to Auto-Fill
2018-02-27 Malfunction None No Display/Image
2018-02-27 Malfunction None Device Operates Differently Than Expected
2018-02-25 Malfunction None Device Displays Incorrect Message
2018-02-25 Malfunction None Gas/Air Leak
2018-02-23 Malfunction None Failure to Sense, Device Operates Differently Than Expected
2018-02-23 Malfunction None Device Displays Incorrect Message
2018-02-23 Malfunction None Leak/Splash
2018-02-23 Malfunction None Physical Property Issue
2018-02-23 Malfunction None Device Operates Differently Than Expected
2018-02-22 Malfunction None Device Operates Differently Than Expected
2018-02-22 Malfunction None Device Operates Differently Than Expected
2018-02-22 Malfunction None Defective Component
2018-02-21 Malfunction None Device Displays Incorrect Message
2018-02-21 Malfunction None Device Displays Incorrect Message
2018-02-21 Malfunction None Incorrect Or Inadequate Test Results
2018-02-21 Malfunction None Noise, Audible
2018-02-21 Malfunction None Noise, Audible
2018-02-20 Malfunction None Loss of Power
2018-02-19 Malfunction None Failure to Charge
2018-02-19 Malfunction None Break, Detachment Of Device Component
2018-02-19 Malfunction None Device Operates Differently Than Expected, Material Distortion
2018-02-19 Malfunction None Device Displays Incorrect Message
2018-02-18 Malfunction None Failure to Charge
2018-02-18 Malfunction None Device Displays Incorrect Message
2018-02-17 Death None Break, Difficult to Insert, Fitting Problem
2018-02-16 Malfunction None Device Alarm System
2018-02-16 Malfunction None Break
2018-02-15 Malfunction None Device Operates Differently Than Expected
2018-02-15 Malfunction None Failure to Power Up
2018-02-15 Malfunction None Device Displays Incorrect Message
2018-02-15 Malfunction None Unable to Obtain Readings, Pressure Problem
2018-02-15 Malfunction None Device Operates Differently Than Expected
2018-02-14 Malfunction None Thermal Decomposition of Device, Arcing
2018-02-14 Malfunction None Thermal Decomposition of Device
2018-02-13 Malfunction None Inflation Problem, Noise, Audible
2018-02-13 Malfunction None Device Displays Incorrect Message
2018-02-13 Malfunction None Device Displays Incorrect Message
2018-02-13 Malfunction None Device Displays Incorrect Message
2018-02-12 Malfunction None Break
2018-02-12 Malfunction None Device Displays Incorrect Message
2018-02-12 Malfunction None Device Displays Incorrect Message
2018-02-11 Malfunction None Loss of Power
2018-02-10 Malfunction None Device Displays Incorrect Message
2018-02-10 Death None Adverse Event Without Identified Device or Use Problem
2018-02-09 Malfunction None Defective Component
2018-02-09 Malfunction None Device Operates Differently Than Expected
2018-02-09 Malfunction None Device Displays Incorrect Message
2018-02-08 Malfunction None Inability to Auto-Fill
2018-02-08 Malfunction None Display or Visual Feedback Problem
2018-02-08 Malfunction None Device Displays Incorrect Message
2018-02-08 Malfunction None Material Discolored
2018-02-08 Malfunction None Device Operates Differently Than Expected
2018-02-08 Malfunction None Device Displays Incorrect Message
2018-02-07 Malfunction None Device Displays Incorrect Message
2018-02-07 Malfunction None Device Displays Incorrect Message
2018-02-07 Malfunction None Device Displays Incorrect Message
2018-02-07 Malfunction None Battery Problem
2018-02-07 Death None Device Alarm System, Break, Use of Incorrect Control/Treatment Settings, Difficult to Remove, Improper or Incorrect Procedure or Method
2018-02-07 Malfunction None Device Operates Differently Than Expected
2018-02-05 Malfunction None Device Displays Incorrect Message
2018-02-05 Malfunction None Device Displays Incorrect Message
2018-02-05 Malfunction None Device Inoperable, Device Operates Differently Than Expected
2018-02-05 Malfunction None Inability to Auto-Fill
2018-02-03 Malfunction None Device Displays Incorrect Message
2018-02-02 Malfunction None Low Battery
2018-02-02 Malfunction None Device Displays Incorrect Message
2018-02-01 Malfunction None Device Displays Incorrect Message
2018-02-01 Malfunction None Loss of Power
2018-01-31 Malfunction None Device Displays Incorrect Message
2018-01-31 Malfunction None Device Displays Incorrect Message
2018-01-30 Malfunction None Device Displays Incorrect Message
2018-01-30 Malfunction None Inability to Auto-Fill
2018-01-30 Malfunction None Device Operates Differently Than Expected
2018-01-30 Malfunction None Device Displays Incorrect Message
2018-01-30 Malfunction None Inflation Problem
2018-01-29 Malfunction None Device Operates Differently Than Expected
2018-01-29 Malfunction None Device Displays Incorrect Message
2018-01-29 Malfunction None Crack, Structural Problem, Pressure Problem
2018-01-28 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-28 Malfunction None Filling Problem
2018-01-28 Malfunction None Failure to Cycle
2018-01-28 Malfunction None Device Displays Incorrect Message
2018-01-27 Malfunction None Loss of Power
2018-01-27 Malfunction None Device Displays Incorrect Message
2018-01-26 Malfunction None Device Displays Incorrect Message
2018-01-26 Malfunction None No Display/Image
2018-01-26 Malfunction None Device Displays Incorrect Message
2018-01-25 Malfunction None Battery Problem, Device Operates Differently Than Expected
2018-01-25 Malfunction None Leak/Splash
2018-01-25 Malfunction None No Display/Image, Failure to Power Up
2018-01-24 Malfunction None Device Displays Incorrect Message
2018-01-24 Malfunction None Failure to Zero
2018-01-24 Malfunction None Suction Problem
2018-01-23 Malfunction None Device Operates Differently Than Expected
2018-01-22 Malfunction None Device Displays Incorrect Message
2018-01-20 Malfunction None No Display/Image
2018-01-19 Malfunction None Device Displays Incorrect Message
2018-01-19 Malfunction None Device Displays Incorrect Message
2018-01-19 Malfunction None Device Displays Incorrect Message
2018-01-19 Malfunction None Component Falling, Loss of Power, Battery Problem
2018-01-18 Malfunction None Incorrect Or Inadequate Test Results
2018-01-18 Malfunction None Device Displays Incorrect Message
2018-01-18 Malfunction None Unable to Obtain Readings, Device Displays Incorrect Message
2018-01-17 Malfunction None Gas/Air Leak
2018-01-17 Malfunction None Device Operates Differently Than Expected, Noise, Audible
2018-01-16 Malfunction None Device Displays Incorrect Message
2018-01-16 Malfunction None Hole In Material, Leak/Splash
2018-01-16 Malfunction None Device Stops Intermittently
2018-01-16 Malfunction None Pumping Stopped
2018-01-16 Malfunction None No Display/Image, Failure to Advance, Device Displays Incorrect Message
2018-01-16 Malfunction None Device Operates Differently Than Expected
2018-01-15 Malfunction None Noise, Audible
2018-01-15 Malfunction None Device Operates Differently Than Expected
2018-01-15 Malfunction None Leak/Splash, Noise, Audible
2018-01-14 Malfunction None Device Displays Incorrect Message, Pressure Problem
2018-01-14 Malfunction None Device Displays Incorrect Message
2018-01-13 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-01-12 Malfunction None Device Displays Incorrect Message
2018-01-12 Malfunction None Decrease in Suction, Device Displays Incorrect Message
2018-01-12 Malfunction None Device Operates Differently Than Expected
2018-01-11 Malfunction None Inability to Auto-Fill
2018-01-11 Malfunction None Device Displays Incorrect Message
2018-01-11 Malfunction None Defective Device, Device Displays Incorrect Message
2018-01-10 Malfunction None Device Inoperable, Device Displays Incorrect Message
2018-01-10 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-01-09 Malfunction None Leak/Splash, Device Displays Incorrect Message
2018-01-09 Malfunction None Failure to Power Up
2018-01-09 Malfunction None Leak/Splash
2018-01-09 Malfunction None Break
2018-01-08 Malfunction None Inappropriate or Unexpected Reset
2018-01-08 Malfunction None Defective Component
2018-01-07 Malfunction None Disconnection, Device Displays Incorrect Message
2018-01-06 Malfunction None Device Displays Incorrect Message
2018-01-05 Malfunction None Device Operates Differently Than Expected
2018-01-05 Malfunction None Device Operates Differently Than Expected
2018-01-05 Injury None Fluid/Blood Leak, Difficult to Remove, Device Displays Incorrect Message, Gas/Air Leak
2018-01-05 Malfunction None Device Displays Incorrect Message
2018-01-05 Malfunction None Device Operates Differently Than Expected
2018-01-04 Malfunction None Break
2018-01-04 Malfunction None Decrease in Suction, Device Displays Incorrect Message, Device Operates Differently Than Expected
2018-01-04 Malfunction None Device Operates Differently Than Expected
2018-01-04 Malfunction None Device Displays Incorrect Message
2018-01-04 Malfunction None Failure to Zero
2018-01-03 Malfunction None Device Displays Incorrect Message
2018-01-01 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2018-01-01 Malfunction None Device Displays Incorrect Message
2018-01-01 Malfunction None Decrease in Suction, Occlusion Within Device, Device Displays Incorrect Message
2017-12-31 Malfunction None Leak/Splash
2017-12-31 Death None Adverse Event Without Identified Device or Use Problem
2017-12-30 Malfunction None Device Displays Incorrect Message
2017-12-29 Malfunction None Device Sensing Problem
2017-12-29 Malfunction None Device Displays Incorrect Message
2017-12-29 Malfunction None Failure to Read Input Signal
2017-12-29 Malfunction None Failure to Charge
2017-12-28 Malfunction None Device Displays Incorrect Message
2017-12-27 Malfunction None Device Operates Differently Than Expected
2017-12-27 Malfunction None Device Operates Differently Than Expected
2017-12-27 Malfunction None Device Operates Differently Than Expected
2017-12-27 Malfunction None Device Operates Differently Than Expected
2017-12-27 Malfunction None Inability to Auto-Fill, Calibration Problem
2017-12-27 Malfunction None Device Inoperable
2017-12-26 Malfunction None Device Operates Differently Than Expected
2017-12-26 Malfunction None Failure to Read Input Signal, Device Inoperable, Pressure Problem
2017-12-26 Malfunction None Device Displays Incorrect Message
2017-12-26 Malfunction None Device Displays Incorrect Message
2017-12-26 Malfunction None Inflation Problem
2017-12-25 Malfunction None Air Leak
2017-12-23 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-12-22 Malfunction None No Display/Image
2017-12-22 Malfunction None Device Displays Incorrect Message
2017-12-21 Malfunction None Device Operates Differently Than Expected
2017-12-21 Malfunction None Device Operates Differently Than Expected
2017-12-20 Malfunction None No Display/Image
2017-12-20 Malfunction None Reset Problem
2017-12-20 Malfunction None Incorrect Or Inadequate Test Results
2017-12-20 Malfunction None Device Displays Incorrect Message
2017-12-20 Malfunction None Incorrect Or Inadequate Test Results
2017-12-20 Malfunction None Device Displays Incorrect Message
2017-12-20 Death None Unable to Obtain Readings, Device Displays Incorrect Message
2017-12-19 Malfunction None Battery Problem
2017-12-18 Malfunction None Device Operates Differently Than Expected
2017-12-18 Malfunction None Device Operates Differently Than Expected
2017-12-18 Malfunction None Device Displays Incorrect Message, Charging Problem
2017-12-18 Malfunction None Device Operates Differently Than Expected
2017-12-16 Death None Bent, Kinked, Difficult to Remove
2017-12-16 Malfunction None Device Displays Incorrect Message
2017-12-15 Malfunction None No Display/Image
2017-12-15 Malfunction None Device Inoperable
2017-12-15 Malfunction None Leak/Splash, Device Operates Differently Than Expected
2017-12-14 Malfunction None Device Displays Incorrect Message
2017-12-13 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-12-12 Malfunction None Device Operates Differently Than Expected
2017-12-12 Death None Adverse Event Without Identified Device or Use Problem
2017-12-11 Malfunction None Device Operates Differently Than Expected
2017-12-11 Malfunction None Device Operates Differently Than Expected
2017-12-08 Malfunction None Defective Device
2017-12-08 Malfunction None Device Displays Incorrect Message
2017-12-08 Malfunction None Device Operates Differently Than Expected
2017-12-07 Malfunction None Device Displays Incorrect Message
2017-12-07 Malfunction None Loss of Power
2017-12-07 Malfunction None Leak/Splash
2017-12-06 Malfunction None Device Operates Differently Than Expected
2017-12-06 Malfunction None Leak/Splash
2017-12-06 Malfunction None Device Displays Incorrect Message
2017-12-06 Malfunction None Defective Device
2017-12-06 Malfunction None Device Displays Incorrect Message
2017-12-06 Malfunction None Charging Problem
2017-12-06 Malfunction None Loss of Power
2017-12-05 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-12-05 Malfunction None Device Displays Incorrect Message
2017-12-05 Malfunction None Inability to Auto-Fill
2017-12-05 Malfunction None Leak/Splash
2017-12-05 Malfunction None Device Displays Incorrect Message
2017-12-05 Malfunction None Device Operates Differently Than Expected
2017-12-04 Malfunction None Failure to Cycle
2017-12-04 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-12-04 Malfunction None Device Displays Incorrect Message
2017-12-04 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-12-02 Malfunction None Device Displays Incorrect Message
2017-12-01 Malfunction None No Display/Image
2017-11-30 Malfunction None Failure to Power Up
2017-11-30 Malfunction None No Display/Image, Self-Activation or Keying, Device Displays Incorrect Message
2017-11-29 Death None Device Inoperable, Device Displays Incorrect Message
2017-11-29 Malfunction None Break, Moisture or Humidity Problem
2017-11-29 Malfunction None Inability to Auto-Fill, Device Displays Incorrect Message
2017-11-29 Malfunction None Device Displays Incorrect Message
2017-11-28 Malfunction None Device Operates Differently Than Expected
2017-11-28 Malfunction None Device Displays Incorrect Message
2017-11-28 Death None Unable to Obtain Readings
2017-11-28 Malfunction None Calibration Problem
2017-11-28 Malfunction None Device Displays Incorrect Message
2017-11-28 Death None Communication or Transmission Problem
2017-11-28 Malfunction None Failure to Power Up, Battery Problem
2017-11-28 Malfunction None Device Operates Differently Than Expected
2017-11-27 Malfunction None Device Displays Incorrect Message
2017-11-27 Malfunction None Device Displays Incorrect Message
2017-11-25 Malfunction None Device Displays Incorrect Message
2017-11-25 Malfunction None Loss of Power
2017-11-24 Malfunction None Device Inoperable
2017-11-24 Malfunction None Material Rupture, Device Inoperable
2017-11-23 Death None Occlusion Within Device
2017-11-23 Malfunction None Device Displays Incorrect Message
2017-11-22 Malfunction None Device Displays Incorrect Message
2017-11-22 Malfunction None Device Inoperable
2017-11-22 Malfunction None Device Displays Incorrect Message
2017-11-22 Malfunction None Failure to Power Up
2017-11-22 Malfunction None Device Operates Differently Than Expected
2017-11-22 Malfunction None Battery Problem
2017-11-21 Malfunction None Failure to Power Up
2017-11-21 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-11-21 Malfunction None Device Operates Differently Than Expected
2017-11-21 Malfunction None Device Displays Incorrect Message
2017-11-21 Malfunction None Device Displays Incorrect Message
2017-11-20 Malfunction None Device Displays Incorrect Message
2017-11-20 Malfunction None Inability to Auto-Fill
2017-11-20 Malfunction None Device Operates Differently Than Expected
2017-11-19 Malfunction None Device Displays Incorrect Message
2017-11-19 Malfunction None Device Displays Incorrect Message
2017-11-19 Malfunction None Device Displays Incorrect Message
2017-11-17 Malfunction None No Display/Image
2017-11-17 Malfunction None Loss of Power
2017-11-17 Malfunction None Computer Operating System Problem
2017-11-17 Malfunction None Break
2017-11-17 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-11-17 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-11-17 Malfunction None Inability to Auto-Fill
2017-11-16 Malfunction None Device Operates Differently Than Expected
2017-11-16 Malfunction None Contamination, Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-11-15 Malfunction None Device Displays Incorrect Message
2017-11-15 Malfunction None Inability to Auto-Fill, Failure to Calibrate, Failure of Device to Self-Test
2017-11-14 Malfunction None Output below Specifications
2017-11-14 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-11-14 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-11-14 Malfunction None Device Displays Incorrect Message
2017-11-14 Malfunction None Device Displays Incorrect Message
2017-11-14 Malfunction None Device Displays Incorrect Message
2017-11-14 Malfunction None Loss of Power
2017-11-14 Malfunction None Failure to Calibrate
2017-11-13 Malfunction None Inability to Auto-Fill, Disconnection, Product Quality Problem
2017-11-13 Malfunction None Poor Quality Image
2017-11-13 Malfunction None Fluid/Blood Leak, Device Displays Incorrect Message
2017-11-12 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-11-11 Malfunction None Fluid/Blood Leak, Device Displays Incorrect Message, Reset Problem
2017-11-11 Malfunction None Device Displays Incorrect Message
2017-11-10 Death None Device Alarm System, Device Operates Differently Than Expected
2017-11-09 Malfunction None Device Displays Incorrect Message
2017-11-09 Malfunction None Device Contamination with Body Fluid
2017-11-09 Malfunction None Failure to Calibrate
2017-11-09 Malfunction None Battery Problem
2017-11-08 Malfunction None Device Operates Differently Than Expected
2017-11-08 Malfunction None Device Displays Incorrect Message, Charging Problem
2017-11-07 Malfunction None No Display/Image
2017-11-07 Malfunction None Device Displays Incorrect Message
2017-11-07 Death None Loss of Power, Defective Component
2017-11-07 Malfunction None Device Displays Incorrect Message
2017-11-07 Malfunction None Device Displays Incorrect Message
2017-11-07 Malfunction None Noise, Audible
2017-11-07 Malfunction None Device Displays Incorrect Message
2017-11-06 Malfunction None Image Display Error/Artifact
2017-11-06 Malfunction None Leak/Splash
2017-11-06 Malfunction None Device Displays Incorrect Message
2017-11-05 Malfunction None Image Display Error/Artifact, Mechanical Problem
2017-11-03 Malfunction None Noise, Audible
2017-11-02 Malfunction None Device Displays Incorrect Message
2017-11-01 Malfunction None Break
2017-11-01 Malfunction None Inability to Auto-Fill
2017-11-01 Malfunction None Inability to Auto-Fill
2017-10-31 Malfunction None Computer Operating System Problem
2017-10-31 Malfunction None Device Displays Incorrect Message
2017-10-31 Malfunction None Decrease in Suction, Device Displays Incorrect Message
2017-10-31 Malfunction None Device Displays Incorrect Message
2017-10-30 Malfunction None Failure of Device to Self-Test
2017-10-30 Malfunction None Device Displays Incorrect Message
2017-10-30 Malfunction None Device Displays Incorrect Message
2017-10-30 Malfunction None Leak/Splash
2017-10-30 Malfunction None Device Displays Incorrect Message
2017-10-30 Malfunction None Material Discolored
2017-10-29 Malfunction None Device Displays Incorrect Message
2017-10-27 Malfunction None Device Displays Incorrect Message
2017-10-26 Malfunction None No Display/Image
2017-10-25 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-10-24 Malfunction None Device Inoperable
2017-10-24 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally
2017-10-24 Malfunction None Break, Failure to Power Up
2017-10-24 Malfunction None Inability to Auto-Fill
2017-10-24 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally
2017-10-24 Malfunction None Device Displays Incorrect Message
2017-10-23 Malfunction None Failure to Read Input Signal, Device Displays Incorrect Message
2017-10-23 Death None Device Displays Incorrect Message
2017-10-23 Injury None Loss of Power, Device Inoperable
2017-10-23 Malfunction None Device Displays Incorrect Message
2017-10-23 Malfunction None Leak/Splash, Device Displays Incorrect Message
2017-10-22 Injury None Fracture
2017-10-22 Malfunction None Pumping Stopped, Device Displays Incorrect Message
2017-10-21 Malfunction None Failure to Reset, Device Displays Incorrect Message
2017-10-21 Malfunction None Device Displays Incorrect Message
2017-10-20 Malfunction None Leak/Splash
2017-10-20 Malfunction None Device Operates Differently Than Expected
2017-10-20 Malfunction None Leak/Splash, Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-10-20 Injury None Device Operates Differently Than Expected
2017-10-18 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-10-18 Malfunction None Device Operates Differently Than Expected
2017-10-16 Malfunction None Device Displays Incorrect Message
2017-10-16 Malfunction None Inability to Auto-Fill
2017-10-16 Malfunction None Device Displays Incorrect Message
2017-10-15 Malfunction None Device Displays Incorrect Message
2017-10-15 Malfunction None Device Operates Differently Than Expected
2017-10-13 Malfunction None Device Displays Incorrect Message
2017-10-13 Malfunction None Device Sensing Problem
2017-10-13 Malfunction None Device Displays Incorrect Message
2017-10-12 Malfunction None Premature Discharge of Battery
2017-10-11 Malfunction None Device Displays Incorrect Message
2017-10-11 Malfunction None No Display/Image, Loss of Power
2017-10-11 Malfunction None Battery Problem
2017-10-11 Malfunction None Failure of Device to Self-Test
2017-10-10 Malfunction None Device Displays Incorrect Message
2017-10-10 Malfunction None Device Operates Differently Than Expected
2017-10-10 Malfunction None Device Displays Incorrect Message
2017-10-10 Malfunction None Battery Problem
2017-10-10 Malfunction None No Display/Image
2017-10-09 Malfunction None Loss of Power
2017-10-09 Malfunction None Device Displays Incorrect Message
2017-10-09 Malfunction None Loss of Power, Device Inoperable
2017-10-09 Malfunction None No Display/Image
2017-10-09 Malfunction None Device Displays Incorrect Message
2017-10-09 Malfunction None Device Operates Differently Than Expected
2017-10-06 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-10-05 Malfunction None Device Displays Incorrect Message
2017-10-04 Malfunction None No Device Output
2017-10-04 Malfunction None No Display/Image, Device Stops Intermittently
2017-10-04 Malfunction None Device Displays Incorrect Message, Calibration Problem
2017-10-04 Malfunction None Computer Operating System Problem
2017-10-03 Malfunction None Disconnection, Device Operates Differently Than Expected
2017-10-03 Malfunction None Device Displays Incorrect Message
2017-10-03 Malfunction None Device Operates Differently Than Expected
2017-10-02 Malfunction None Calibration Problem
2017-10-02 Malfunction None Failure of Device to Self-Test
2017-10-02 Malfunction None Device Operates Differently Than Expected
2017-09-29 Malfunction None Device Displays Incorrect Message
2017-09-29 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-09-28 Malfunction None Detachment Of Device Component
2017-09-28 Malfunction None Battery Problem
2017-09-27 Malfunction None Loss of Power
2017-09-27 Malfunction None Device Operates Differently Than Expected
2017-09-27 Malfunction None Break
2017-09-27 Malfunction None Failure to Power Up, Device Operates Differently Than Expected
2017-09-26 Malfunction None Device Operates Differently Than Expected
2017-09-26 Malfunction None Device Operates Differently Than Expected
2017-09-26 Malfunction None Device Displays Incorrect Message
2017-09-26 Malfunction None Device Displays Incorrect Message
2017-09-26 Malfunction None Output Problem
2017-09-25 Malfunction None Failure to Calibrate, Device Displays Incorrect Message
2017-09-24 Malfunction None Loss of Power, Electrical Shorting
2017-09-24 Malfunction None Device Displays Incorrect Message
2017-09-24 Malfunction None Insufficient Information
2017-09-23 Malfunction None Device Displays Incorrect Message
2017-09-22 Malfunction None Leak/Splash
2017-09-21 Malfunction None Inability to Auto-Fill, Device Operates Differently Than Expected
2017-09-21 Malfunction None No Display/Image, Failure to Power Up
2017-09-21 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-09-20 Malfunction None Battery Problem, Device Operates Differently Than Expected
2017-09-20 Malfunction None Device Operates Differently Than Expected
2017-09-19 Malfunction None Break
2017-09-19 Malfunction None Device Displays Incorrect Message
2017-09-19 Malfunction None Increase in Pressure, Device Operates Differently Than Expected
2017-09-19 Malfunction None Battery Problem
2017-09-18 Malfunction None Device Operates Differently Than Expected
2017-09-18 Malfunction None Device Operates Differently Than Expected
2017-09-16 Malfunction None Device Operates Differently Than Expected
2017-09-15 Malfunction None Device Displays Incorrect Message
2017-09-14 Malfunction None Failure To Run On AC/DC, Loss of Power, Battery Problem
2017-09-14 Malfunction None Device Displays Incorrect Message
2017-09-14 Malfunction None No Display/Image
2017-09-13 Malfunction None Failure of Device to Self-Test
2017-09-12 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-09-12 Malfunction None Device Operates Differently Than Expected
2017-09-12 Malfunction None Device Displays Incorrect Message
2017-09-11 Malfunction None Appropriate Term/Code Not Available
2017-09-11 Malfunction None Device Alarm System, Device Displays Incorrect Message
2017-09-10 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-09-10 Malfunction None Device Displays Incorrect Message
2017-09-08 Malfunction None Loss of Power
2017-09-08 Malfunction None Failure to Charge
2017-09-07 Malfunction None Device Inoperable, Out-Of-Box Failure
2017-09-07 Malfunction None Device Maintenance Issue, Device Displays Incorrect Message
2017-09-07 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-09-06 Malfunction None Device Displays Incorrect Message
2017-09-06 Malfunction None Device Displays Incorrect Message, Chemical Spillage
2017-09-06 Malfunction None Device Operates Differently Than Expected
2017-09-05 Malfunction None Break
2017-09-05 Malfunction None Pressure Problem
2017-09-05 Malfunction None Inability to Auto-Fill
2017-09-05 Malfunction None Device Displays Incorrect Message
2017-09-04 Malfunction None Device Alarm System, Device Stops Intermittently
2017-09-04 Malfunction None Leak/Splash
2017-09-02 Malfunction None Device Displays Incorrect Message
2017-09-02 Malfunction None Loss of Power
2017-09-01 Malfunction None Device Displays Incorrect Message
2017-09-01 Malfunction None Loss of Power
2017-08-31 Malfunction None Device Displays Incorrect Message
2017-08-31 Malfunction None Device Maintenance Issue
2017-08-30 Malfunction None Device Inoperable
2017-08-30 Death None Difficult to Insert, Failure to Advance, Device Displays Incorrect Message
2017-08-29 Malfunction None No Display/Image
2017-08-29 Malfunction None Device Operates Differently Than Expected
2017-08-29 Malfunction None No Display/Image
2017-08-29 Malfunction None Device Displays Incorrect Message, Improper Alarm
2017-08-29 Malfunction None Battery Problem
2017-08-29 Malfunction None Device Operates Differently Than Expected
2017-08-29 Malfunction None Device Inoperable
2017-08-28 Malfunction None No Display/Image
2017-08-28 Malfunction None No Display/Image, Failure to Power Up
2017-08-28 Malfunction None Battery Problem
2017-08-25 Malfunction None Break
2017-08-25 Malfunction None Battery Problem
2017-08-25 Malfunction None Battery Problem
2017-08-25 Malfunction None Filling Problem, Device Displays Incorrect Message
2017-08-25 Death None Material Rupture
2017-08-24 Malfunction None Device Displays Incorrect Message
2017-08-24 Malfunction None No Display/Image
2017-08-24 Malfunction None Battery Problem
2017-08-24 Malfunction None Calibration Problem
2017-08-22 Malfunction None Device Displays Incorrect Message
2017-08-22 Malfunction None Leak/Splash, Failure to Calibrate
2017-08-21 Malfunction None Failure to Calibrate
2017-08-21 Malfunction None Programming Issue
2017-08-21 Malfunction None No Display/Image
2017-08-20 Malfunction None Device Displays Incorrect Message
2017-08-19 Malfunction None Suction Problem
2017-08-19 Malfunction None No Display/Image
2017-08-19 Malfunction None Device Stops Intermittently
2017-08-18 Malfunction None Device Displays Incorrect Message, Gas/Air Leak
2017-08-18 Malfunction None Failure to Power Up
2017-08-18 Malfunction None Air Leak, Device Displays Incorrect Message
2017-08-17 Malfunction None Device Displays Incorrect Message
2017-08-17 Malfunction None Battery Problem
2017-08-17 Malfunction None Failure of Device to Self-Test
2017-08-17 Malfunction None Device Displays Incorrect Message
2017-08-17 Malfunction None Disconnection
2017-08-17 Malfunction None No Display/Image
2017-08-17 Malfunction None Decrease in Suction, Device Displays Incorrect Message
2017-08-17 Malfunction None Device Displays Incorrect Message
2017-08-17 Malfunction None Device Displays Incorrect Message
2017-08-16 Malfunction None Device Displays Incorrect Message
2017-08-16 Malfunction None Battery Problem
2017-08-16 Malfunction None Decrease in Suction, Device Displays Incorrect Message
2017-08-16 Malfunction None Device Displays Incorrect Message
2017-08-16 Malfunction None Battery Problem
2017-08-16 Malfunction None Break
2017-08-16 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-08-16 Malfunction None Device Operates Differently Than Expected
2017-08-15 Malfunction None Device Displays Incorrect Message
2017-08-15 Malfunction None Battery Problem
2017-08-15 Malfunction None Inability to Auto-Fill
2017-08-15 Malfunction None Device Operates Differently Than Expected
2017-08-15 Malfunction None Device Operates Differently Than Expected
2017-08-14 Malfunction None Device Displays Incorrect Message
2017-08-13 Malfunction None Inability to Auto-Fill
2017-08-13 Malfunction None Failure to Sense, Failure to Calibrate
2017-08-12 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-08-12 Malfunction None Inability to Auto-Fill
2017-08-12 Malfunction None Pumping Stopped
2017-08-12 Malfunction None Device Displays Incorrect Message
2017-08-11 Malfunction None No Display/Image
2017-08-11 Malfunction None Device Displays Incorrect Message
2017-08-11 Malfunction None Break
2017-08-11 Malfunction None Failure of Device to Self-Test
2017-08-11 Malfunction None Device Displays Incorrect Message
2017-08-10 Malfunction None Failure to Shut Off
2017-08-10 Malfunction None Device Displays Incorrect Message
2017-08-10 Malfunction None Failure to Charge, Battery Problem
2017-08-10 Malfunction None Device Displays Incorrect Message
2017-08-09 Malfunction None Leak/Splash, Device Operates Differently Than Expected
2017-08-08 Malfunction None Device Alarm System
2017-08-08 Malfunction None Incorrect Or Inadequate Test Results
2017-08-08 Malfunction None Device Alarm System
2017-08-07 Malfunction None Device Operates Differently Than Expected
2017-08-07 Malfunction None Leak/Splash
2017-08-07 Malfunction None Pumping Stopped
2017-08-07 Malfunction None Loss of Power
2017-08-07 Malfunction None Failure to Power Up, Defective Component
2017-08-07 Malfunction None Device Displays Incorrect Message
2017-08-06 Malfunction None Device Displays Incorrect Message
2017-08-05 Malfunction None Filling Problem
2017-08-05 Malfunction None No Display/Image
2017-08-04 Malfunction None Suction Problem
2017-08-04 Malfunction None Leak/Splash
2017-08-04 Malfunction None Leak/Splash
2017-08-03 Malfunction None Device Displays Incorrect Message
2017-08-03 Malfunction None Inability to Auto-Fill
2017-08-02 Malfunction None Device Displays Incorrect Message
2017-08-02 Malfunction None Device Operates Differently Than Expected
2017-08-02 Malfunction None No Display/Image, Improper Device Output
2017-08-01 Malfunction None Device Displays Incorrect Message
2017-08-01 Malfunction None Failure to Charge
2017-08-01 Malfunction None Break
2017-07-31 Malfunction None Device Displays Incorrect Message
2017-07-31 Malfunction None Device Operates Differently Than Expected
2017-07-31 Malfunction None Device Maintenance Issue
2017-07-31 Malfunction None Inability to Auto-Fill
2017-07-28 Malfunction None Device Displays Incorrect Message, Noise, Audible
2017-07-28 Malfunction None Device Operates Differently Than Expected
2017-07-27 Malfunction None No Display/Image
2017-07-27 Malfunction None Device Operates Differently Than Expected
2017-07-26 Malfunction None Failure to Calibrate, Device Displays Incorrect Message
2017-07-26 Malfunction None No Display/Image
2017-07-26 Malfunction None No Display/Image, Device Displays Incorrect Message
2017-07-26 Malfunction None Device Operates Differently Than Expected
2017-07-26 Malfunction None Device Displays Incorrect Message
2017-07-26 Malfunction None Leak/Splash
2017-07-25 Malfunction None Device Displays Incorrect Message
2017-07-25 Malfunction None Device Alarm System, Loss of Power
2017-07-25 Malfunction None Communication or Transmission Problem
2017-07-25 Malfunction None Device Displays Incorrect Message
2017-07-24 Malfunction None Device Operates Differently Than Expected
2017-07-24 Malfunction None Incorrect Or Inadequate Test Results
2017-07-24 Malfunction None Device Operates Differently Than Expected
2017-07-22 Injury None Backflow, Hole In Material, Material Rupture
2017-07-21 Malfunction None Device Displays Incorrect Message, Computer Operating System Problem
2017-07-20 Malfunction None Device Displays Incorrect Message
2017-07-20 Malfunction None Device Displays Incorrect Message
2017-07-20 Malfunction None Device Displays Incorrect Message
2017-07-20 Malfunction None Device Displays Incorrect Message
2017-07-20 Malfunction None Device Operates Differently Than Expected
2017-07-20 Malfunction None Material Distortion
2017-07-19 Malfunction None Failure to Charge, Device Inoperable
2017-07-19 Malfunction None Device Operates Differently Than Expected
2017-07-19 Malfunction None Failure to Charge, Low Battery
2017-07-18 Malfunction None Device Operates Differently Than Expected
2017-07-18 Malfunction None Erratic or Intermittent Display
2017-07-18 Malfunction None Loss of Power, Low Battery
2017-07-18 Malfunction None Device Contamination with Chemical or Other Material
2017-07-17 Malfunction None Device Displays Incorrect Message
2017-07-17 Malfunction None Defective Component
2017-07-17 Malfunction None Air Leak
2017-07-17 Malfunction None Inability to Auto-Fill, Device Stops Intermittently
2017-07-17 Malfunction None Display or Visual Feedback Problem, Misconnection
2017-07-16 Malfunction None Device Displays Incorrect Message
2017-07-15 Malfunction None Device Displays Incorrect Message
2017-07-15 Malfunction None Device Displays Incorrect Message
2017-07-15 Malfunction None Device Displays Incorrect Message
2017-07-14 Malfunction None Device Operates Differently Than Expected
2017-07-14 Malfunction None Device Displays Incorrect Message
2017-07-14 Malfunction None Device Operates Differently Than Expected
2017-07-14 Malfunction None Inability to Auto-Fill
2017-07-14 Malfunction None Device Operates Differently Than Expected
2017-07-14 Malfunction None No Display/Image
2017-07-14 Malfunction None Device Displays Incorrect Message
2017-07-13 Malfunction None No Display/Image, Image Display Error/Artifact
2017-07-13 Malfunction None Device Displays Incorrect Message
2017-07-13 Malfunction None Unable to Obtain Readings, Device Inoperable, Pressure Problem
2017-07-13 Malfunction None Device Displays Incorrect Message
2017-07-13 Malfunction None Device Inoperable
2017-07-12 Malfunction None No Display/Image, Device Damaged Prior to Use, Device Displays Incorrect Message
2017-07-12 Malfunction None Decrease in Suction
2017-07-12 Malfunction None Loss of Power
2017-07-12 Malfunction None No Display/Image
2017-07-12 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-07-11 Malfunction None Device Displays Incorrect Message
2017-07-11 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally
2017-07-11 Malfunction None Device Displays Incorrect Message
2017-07-11 Malfunction None Device Displays Incorrect Message
2017-07-10 Malfunction None Device Displays Incorrect Message
2017-07-10 Malfunction None Leak/Splash
2017-07-10 Malfunction None Device Stops Intermittently
2017-07-10 Malfunction None Device Displays Incorrect Message
2017-07-07 Malfunction None Connection Problem
2017-07-06 Malfunction None Power Problem
2017-07-06 Malfunction None Moisture Damage, Device Displays Incorrect Message
2017-07-06 Malfunction None Device Displays Incorrect Message
2017-07-05 Malfunction None Loss of Power
2017-07-05 Malfunction None Battery Problem
2017-07-05 Malfunction None Loss of Power
2017-07-05 Malfunction None No Display/Image
2017-07-05 Malfunction None Battery Problem
2017-07-05 Malfunction None No Display/Image
2017-07-05 Malfunction None Device Displays Incorrect Message
2017-07-03 Malfunction None Output below Specifications
2017-07-02 Malfunction None Component Missing, Out-Of-Box Failure
2017-07-01 Malfunction None Filling Problem, Failure to Power Up, Device Displays Incorrect Message
2017-07-01 Malfunction None Device Displays Incorrect Message
2017-06-30 Malfunction None Device Displays Incorrect Message
2017-06-30 Malfunction None Failure of Device to Self-Test
2017-06-29 Malfunction None Device Maintenance Issue
2017-06-28 Malfunction None No Display/Image
2017-06-28 Malfunction None Device Operates Differently Than Expected
2017-06-28 Malfunction None Device Operates Differently Than Expected
2017-06-27 Malfunction None Device Emits Odor, Device Displays Incorrect Message
2017-06-27 Malfunction None Device Displays Incorrect Message
2017-06-26 Malfunction None Device Stops Intermittently, Device Operates Differently Than Expected
2017-06-26 Malfunction None Device Operates Differently Than Expected
2017-06-24 Malfunction None Inability to Auto-Fill
2017-06-23 Malfunction None Device Operates Differently Than Expected, Power Problem
2017-06-23 Malfunction None Leak/Splash
2017-06-23 Malfunction None Device Sensing Problem
2017-06-22 Malfunction None Premature Discharge of Battery
2017-06-22 Malfunction None Sticking
2017-06-21 Malfunction None Visual Prompts will not Clear, Device Displays Incorrect Message
2017-06-21 Malfunction None Calibration Error
2017-06-21 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-06-21 Malfunction None Battery Problem
2017-06-21 Malfunction None Pumping Stopped
2017-06-21 Malfunction None Device Displays Incorrect Message
2017-06-19 Malfunction None Device Displays Incorrect Message
2017-06-19 Malfunction None Loss of Power
2017-06-19 Malfunction None Device Displays Incorrect Message
2017-06-18 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-06-17 Malfunction None Device Displays Incorrect Message
2017-06-17 Malfunction None Device Maintenance Issue, Device Displays Incorrect Message
2017-06-16 Malfunction None Device Operates Differently Than Expected
2017-06-16 Malfunction None Device Displays Incorrect Message
2017-06-15 Malfunction None Inability to Auto-Fill
2017-06-15 Malfunction None Leak/Splash
2017-06-15 Malfunction None Electrical /Electronic Property Problem
2017-06-14 Malfunction None Burst Container or Vessel, Device Displays Incorrect Message, Pressure Problem
2017-06-14 Malfunction None Device Alarm System, Backflow
2017-06-12 Malfunction None Leak/Splash
2017-06-12 Malfunction None Device Inoperable
2017-06-12 Malfunction None Leak/Splash
2017-06-11 Malfunction None Device Displays Incorrect Message
2017-06-05 Death None Device Displays Incorrect Message
2017-06-05 Malfunction None Inaccurate Synchronization
2017-06-05 Death None Device Displays Incorrect Message
2017-05-31 Death None Adverse Event Without Identified Device or Use Problem
2017-05-28 Death None Adverse Event Without Identified Device or Use Problem
2017-05-01 Death None Air Leak, Device Displays Incorrect Message
2017-04-21 Death None Adverse Event Without Identified Device or Use Problem
2017-04-03 Death None Device Operates Differently Than Expected
2017-02-10 Injury None Loss of Power, Device Displays Incorrect Message
2017-01-22 Malfunction None Device Displays Incorrect Message
2016-12-05 Malfunction None Leak/Splash, Device Displays Incorrect Message
2016-11-17 Death None Failure to Pump, Device Displays Incorrect Message, Device Operates Differently Than Expected
2016-08-09 Death None Device Displays Incorrect Message
2015-12-09 Death None Device Operates Differently Than Expected
2015-07-12 Death None Device Displays Incorrect Message
2015-05-07 Death None Leak/Splash, Device Displays Incorrect Message
2015-04-20 Malfunction None Inability to Auto-Fill, Device Displays Incorrect Message, Insufficient Information
2015-04-19 Injury None Backflow, Device Displays Incorrect Message, Device Operates Differently Than Expected
2015-04-11 Malfunction None Device Displays Incorrect Message
2015-03-26 Death None Inability to Auto-Fill, Device Displays Incorrect Message
2014-12-01 Malfunction None Device Displays Incorrect Message
2014-10-11 Malfunction None Break, Device Operates Differently Than Expected, Positioning Problem
2014-07-07 Malfunction None Device Alarm System, Device Displays Incorrect Message
2014-07-02 Death None Device Alarm System
2014-05-12 Death None Unable to Obtain Readings
2014-04-10 Death None Low Audible Alarm, Component Falling, Moisture Damage, Failure to Power Up
2014-04-03 Death None Device Operates Differently Than Expected
2014-03-31 Malfunction None Image Display Error/Artifact
2014-03-29 Malfunction None Device Displays Incorrect Message
2014-03-27 Malfunction None Low Readings
2014-03-27 Malfunction None Device Displays Incorrect Message
2014-03-26 Malfunction None Device Displays Incorrect Message
2014-03-26 Malfunction None Device Displays Incorrect Message
2014-03-25 Malfunction None Device Displays Incorrect Message
2014-03-25 Malfunction None Device Inoperable, Device Displays Incorrect Message
2014-03-25 Malfunction None Device Operates Differently Than Expected
2014-03-25 Malfunction None Device Alarm System, Loss of Power
2014-03-24 Malfunction None Calibration Error
2014-03-24 Malfunction None Material Discolored
2014-03-23 Malfunction None Device Displays Incorrect Message
2014-03-22 Malfunction None Device Displays Incorrect Message
2014-03-21 Malfunction None Mechanical Problem, Device Displays Incorrect Message
2014-03-20 Malfunction None Device Displays Incorrect Message
2014-03-18 Malfunction None Device Displays Incorrect Message
2014-03-17 Malfunction None Device Displays Incorrect Message
2014-03-14 Malfunction None Device Operates Differently Than Expected
2014-03-13 Malfunction None Device Displays Incorrect Message
2014-03-13 Malfunction None Device Displays Incorrect Message
2014-03-12 Malfunction None Image Display Error/Artifact
2014-03-12 Malfunction None Device Displays Incorrect Message
2014-03-12 Malfunction None Device Inoperable, Device Displays Incorrect Message
2014-03-11 Malfunction None Device Displays Incorrect Message
2014-03-11 Malfunction None Device Displays Incorrect Message
2014-03-11 Malfunction None Device Displays Incorrect Message
2014-03-11 Malfunction None Device Displays Incorrect Message
2014-03-10 Malfunction None Device Operates Differently Than Expected
2014-03-10 Malfunction None Device Operates Differently Than Expected
2014-03-10 Malfunction None Device Operates Differently Than Expected
2014-03-10 Malfunction None Device Operates Differently Than Expected
2014-03-08 Malfunction None Device Displays Incorrect Message
2014-03-07 Malfunction None Device Displays Incorrect Message
2014-03-07 Malfunction None Device Displays Incorrect Message
2014-03-05 Malfunction None Communication or Transmission Problem
2014-03-05 Malfunction None Leak/Splash, Device Displays Incorrect Message
2014-03-05 Malfunction None No Display/Image, Unable to Obtain Readings
2014-03-04 Malfunction None Device Displays Incorrect Message
2014-03-03 Malfunction None Image Display Error/Artifact
2014-03-02 Malfunction None Device Displays Incorrect Message
2014-03-01 Malfunction None Device Displays Incorrect Message
2014-02-24 Malfunction None Device Displays Incorrect Message
2014-02-24 Malfunction None Device Displays Incorrect Message
2014-01-31 Death None Device Displays Incorrect Message
2014-01-31 Malfunction None Device Inoperable
2014-01-06 Injury None Inflation Problem
2013-12-30 Malfunction None Device Displays Incorrect Message
2013-12-22 Malfunction None Loss of Power
2013-12-22 Malfunction None Device Displays Incorrect Message
2013-12-21 Malfunction None Device Operates Differently Than Expected
2013-12-20 Malfunction None Device Displays Incorrect Message
2013-12-20 Malfunction None Erratic or Intermittent Display, Noise, Audible
2013-12-19 Malfunction None Failure to Power Up
2013-12-19 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2013-12-19 Malfunction None Device Displays Incorrect Message
2013-12-18 Malfunction None Device Displays Incorrect Message
2013-12-17 Malfunction None Device Operates Differently Than Expected
2013-12-16 Malfunction None Device Displays Incorrect Message
2013-12-15 Malfunction None Mechanical Problem, Pressure Problem
2013-12-15 Malfunction None Device Displays Incorrect Message
2013-12-14 Malfunction None None
2013-12-13 Malfunction None Device Displays Incorrect Message
2013-12-11 Malfunction None Device Displays Incorrect Message
2013-12-09 Malfunction None Device Displays Incorrect Message
2013-12-09 Malfunction None Device Operates Differently Than Expected
2013-12-09 Malfunction None Device Displays Incorrect Message
2013-12-08 Malfunction None Image Display Error/Artifact
2013-12-08 Malfunction None Device Displays Incorrect Message
2013-12-07 Malfunction None Device Operates Differently Than Expected
2013-12-06 Malfunction None Device Operates Differently Than Expected, Device Sensing Problem
2013-12-05 Malfunction None Break, Failure to Calibrate
2013-12-05 Malfunction None Device Displays Incorrect Message
2013-12-04 Malfunction None Device Inoperable, Device Displays Incorrect Message
2013-12-03 Malfunction None Device Displays Incorrect Message
2013-12-03 Malfunction None Device Displays Incorrect Message
2013-12-03 Malfunction None Device Displays Incorrect Message
2013-12-03 Malfunction None Device Operates Differently Than Expected
2013-12-02 Malfunction None Device Displays Incorrect Message
2013-12-01 Malfunction None None
2013-11-30 Malfunction None Device Operates Differently Than Expected
2013-11-30 Malfunction None Device Displays Incorrect Message
2013-11-28 Malfunction None Device Displays Incorrect Message
2013-11-28 Malfunction None Device Displays Incorrect Message
2013-11-27 Malfunction None Device Operates Differently Than Expected, Pressure Problem, Activation Failure
2013-11-27 Malfunction None Pressure Problem
2013-11-27 Malfunction None Device Displays Incorrect Message
2013-11-26 Malfunction None Device Displays Incorrect Message
2013-11-26 Malfunction None Break
2013-11-26 Malfunction None Break
2013-11-25 Malfunction None No Display/Image, Device Operates Differently Than Expected
2013-11-25 Malfunction None Device Displays Incorrect Message
2013-11-24 Malfunction None Device Displays Incorrect Message
2013-11-21 Malfunction None Device Operates Differently Than Expected
2013-11-21 Malfunction None Failure to Charge, Power Problem
2013-11-20 Malfunction None Inability to Auto-Fill
2013-11-20 Malfunction None Device Operates Differently Than Expected
2013-11-20 Death None Device Operates Differently Than Expected, Infusion or Flow Problem
2013-11-19 Malfunction None Device Displays Incorrect Message
2013-11-18 Malfunction None Pumping Problem
2013-11-15 Malfunction None Device Displays Incorrect Message
2013-11-15 Malfunction None Device Displays Incorrect Message
2013-11-15 Malfunction None Battery Problem
2013-11-14 Malfunction None Device Operates Differently Than Expected
2013-11-14 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-11-13 Malfunction None Device Displays Incorrect Message
2013-11-13 Malfunction None Device Displays Incorrect Message
2013-11-13 Malfunction None Device Displays Incorrect Message
2013-11-12 Malfunction None Device Inoperable
2013-11-12 Malfunction None Device Displays Incorrect Message
2013-11-12 Malfunction None Device Displays Incorrect Message
2013-11-10 Malfunction None Device Displays Incorrect Message
2013-11-09 Malfunction None None
2013-11-07 Malfunction None Device Operates Differently Than Expected
2013-11-05 Malfunction None Device Displays Incorrect Message
2013-11-05 Malfunction None Device Alarm System, Filling Problem, Device Operates Differently Than Expected
2013-11-05 Malfunction None Device Displays Incorrect Message
2013-11-05 Malfunction None Device Operates Differently Than Expected
2013-11-05 Injury None Failure to Read Input Signal
2013-11-02 Malfunction None Device Displays Incorrect Message
2013-11-01 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2013-11-01 Malfunction None Device Displays Incorrect Message
2013-10-31 Malfunction None Failure to Sense
2013-10-30 Malfunction None Device Displays Incorrect Message
2013-10-30 Malfunction None Charging Problem
2013-10-30 Malfunction None Failure to Power Up
2013-10-29 Malfunction None Device Displays Incorrect Message
2013-10-28 Malfunction None Device Displays Incorrect Message
2013-10-27 Malfunction None Device Inoperable
2013-10-26 Malfunction None Failure to Select Signal
2013-10-25 Malfunction None Device Displays Incorrect Message
2013-10-23 Malfunction None Device Emits Odor, Smoking
2013-10-22 Malfunction None None
2013-10-21 Malfunction None Device Displays Incorrect Message
2013-10-21 Malfunction None No Display/Image
2013-10-20 Malfunction None None
2013-10-19 Malfunction None Device Displays Incorrect Message, Calibration Problem
2013-10-17 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-10-16 Injury None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-10-16 Malfunction None None
2013-10-16 Malfunction None None
2013-10-16 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-10-16 Injury None Loose or Intermittent Connection, Device Displays Incorrect Message
2013-10-15 Malfunction None None
2013-10-14 Malfunction None None
2013-10-14 Malfunction None None
2013-10-12 Malfunction None Device Displays Incorrect Message
2013-10-10 Malfunction None None
2013-10-10 Malfunction None None
2013-10-09 Malfunction None Device Displays Incorrect Message
2013-10-09 Malfunction None None
2013-10-08 Malfunction None None
2013-10-03 Malfunction None None
2013-10-03 Malfunction None Device Operates Differently Than Expected
2013-10-02 Malfunction None None
2013-10-02 Malfunction None None
2013-09-30 Malfunction None Image Display Error/Artifact, Device Stops Intermittently
2013-09-30 Malfunction None Device Displays Incorrect Message
2013-09-30 Malfunction None None
2013-09-30 Malfunction None None
2013-09-29 Malfunction None None
2013-09-26 Malfunction None Device Displays Incorrect Message
2013-09-25 Malfunction None None
2013-09-24 Malfunction None Device Operates Differently Than Expected
2013-09-23 Malfunction None None
2013-09-23 Malfunction None Electrical /Electronic Property Problem
2013-09-21 Injury None Device Displays Incorrect Message
2013-09-19 Malfunction None None
2013-09-18 Malfunction None None
2013-09-17 Injury None Device Displays Incorrect Message
2013-09-16 Injury None Device Displays Incorrect Message
2013-09-15 Injury None Device Operates Differently Than Expected
2013-09-13 Malfunction None None
2013-09-11 Malfunction None Device Displays Incorrect Message
2013-09-06 Malfunction None Erratic or Intermittent Display
2013-09-05 Malfunction None Device Alarm System
2013-09-04 Malfunction None Break
2013-09-03 Malfunction None Device Displays Incorrect Message
2013-09-01 Malfunction None None
2013-09-01 Malfunction None None
2013-08-30 Malfunction None Device Displays Incorrect Message
2013-08-28 Malfunction None None
2013-08-26 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-08-26 Malfunction None Device Displays Incorrect Message
2013-08-23 Malfunction None Device Displays Incorrect Message
2013-08-23 Malfunction None None
2013-08-22 Malfunction None None
2013-08-22 Malfunction None None
2013-08-21 Malfunction None Calibration Problem
2013-08-21 Malfunction None Improper Device Output
2013-08-20 Malfunction None Device Displays Incorrect Message
2013-08-17 Malfunction None None
2013-08-16 Malfunction None None
2013-08-16 Malfunction None Device Displays Incorrect Message
2013-08-15 Malfunction None Device Operates Differently Than Expected
2013-08-14 Injury None Device Displays Incorrect Message
2013-08-14 Malfunction None Connection Problem
2013-08-13 Malfunction None Device Inoperable
2013-08-11 Malfunction None None
2013-08-09 Malfunction None None
2013-08-09 Malfunction None None
2013-08-08 Malfunction None Device Displays Incorrect Message
2013-08-07 Malfunction None Device Displays Incorrect Message
2013-08-06 Malfunction None None
2013-08-05 Malfunction None Failure to Power Up
2013-08-04 Malfunction None None
2013-08-01 Malfunction None None
2013-08-01 Malfunction None None
2013-08-01 Malfunction None None
2013-07-31 Malfunction None None
2013-07-28 Malfunction None Device Displays Incorrect Message
2013-07-26 Malfunction None None
2013-07-22 Malfunction None None
2013-07-19 Death None None
2013-07-17 Malfunction None Sticking, Device Displays Incorrect Message
2013-07-17 Malfunction None Sticking, Device Inoperable, Device Displays Incorrect Message
2013-07-17 Malfunction None Sticking, Device Displays Incorrect Message
2013-07-16 Malfunction None None
2013-07-15 Malfunction None None
2013-07-14 Other None None
2013-07-11 Other None Loss of Power
2013-07-11 Injury None Device Operates Differently Than Expected
2013-07-09 Malfunction None None
2013-07-08 Malfunction None Failure to Power Up, Reset Problem
2013-07-02 Malfunction None None
2013-07-01 Malfunction None Out-Of-Box Failure
2013-06-20 Malfunction None Failure to Power Up, Reset Problem
2013-06-19 Malfunction None None
2013-06-18 Malfunction None None
2013-06-18 Death None None
2013-06-14 Malfunction None Device Displays Incorrect Message
2013-06-12 Malfunction None None
2013-06-11 Malfunction None None
2013-06-03 Malfunction None None
2013-06-03 Malfunction None Device Displays Incorrect Message
2013-05-17 Malfunction None None
2013-05-13 Malfunction None None
2013-05-13 Malfunction None None
2013-05-09 Malfunction None None
2013-05-02 Malfunction None None
2013-05-01 Injury None Device Operates Differently Than Expected
2013-04-30 Death None None
2013-04-16 Malfunction None Device Displays Incorrect Message, Moisture or Humidity Problem
2013-04-13 Malfunction None Improper Device Output
2013-04-13 Malfunction None Device Operates Differently Than Expected
2013-04-12 Malfunction None None
2013-04-10 Death None None
2013-04-09 Malfunction None None
2013-04-01 Malfunction None None
2013-03-31 Malfunction None None
2013-03-31 Injury None Pumping Stopped, Device Operates Differently Than Expected
2013-03-29 Injury None Device Displays Incorrect Message
2013-03-29 Injury None Pressure Problem
2013-03-21 Malfunction None None
2013-03-20 Injury None Device Displays Incorrect Message
2013-03-19 Malfunction None Communication or Transmission Problem
2013-03-14 Malfunction None Device Displays Incorrect Message
2013-03-13 Malfunction None Device Displays Incorrect Message
2013-02-28 Malfunction None None
2013-02-28 Malfunction None Device Operates Differently Than Expected
2013-02-23 Malfunction None None
2013-02-19 Malfunction None None
2013-02-18 Malfunction None None
2013-02-04 Malfunction None None
2013-02-02 Malfunction None None
2013-02-01 Malfunction None None
2013-01-27 Injury None Loss of Power, Failure to Power Up
2013-01-24 Injury None Device Displays Incorrect Message, Device Operates Differently Than Expected
2013-01-24 Malfunction None Device Displays Incorrect Message
2013-01-24 Injury None Device Inoperable, Device Displays Incorrect Message
2013-01-23 Malfunction None None
2013-01-22 Malfunction None None
2013-01-19 Death None None
2013-01-04 Malfunction None None
2013-01-01 Malfunction None Device Operates Differently Than Expected
2013-01-01 Malfunction None Device Displays Incorrect Message
2012-12-24 Malfunction None None
2012-12-17 Malfunction None None
2012-12-13 Malfunction None Loss of Power
2012-12-11 Malfunction None Communication or Transmission Problem
2012-12-11 Malfunction None None
2012-12-10 Malfunction None None
2012-12-10 Malfunction None Device Displays Incorrect Message
2012-12-09 Malfunction None None
2012-12-09 Malfunction None Unable to Obtain Readings
2012-12-09 Malfunction None Device Alarm System
2012-12-05 Malfunction None None
2012-12-04 Malfunction None Device Operates Differently Than Expected
2012-12-04 Malfunction None None
2012-12-03 Malfunction None Device Operates Differently Than Expected
2012-11-20 Malfunction None Device Alarm System
2012-11-19 Malfunction None Device Displays Incorrect Message
2012-11-14 Malfunction None Device Operates Differently Than Expected
2012-11-09 Death None None
2012-11-09 Death None None
2012-11-08 Injury None Device Displays Incorrect Message
2012-11-06 Malfunction None Device Operates Differently Than Expected
2012-11-02 Malfunction None Device Displays Incorrect Message
2012-10-21 Malfunction None Device Operates Differently Than Expected, Pressure Problem
2012-10-20 Death None None
2012-10-12 Malfunction None None
2012-10-10 Malfunction None Device Operates Differently Than Expected
2012-10-10 Malfunction None None
2012-10-09 Malfunction None No Display/Image
2012-10-08 Malfunction None None
2012-10-08 Malfunction None Device Displays Incorrect Message
2012-10-07 Malfunction None None
2012-10-04 Death None None
2012-10-03 Malfunction None None
2012-10-02 Malfunction None Device Displays Incorrect Message
2012-09-26 Malfunction None Loss of Power
2012-09-25 Malfunction None Inability to Auto-Fill, Decrease in Suction
2012-09-23 Malfunction None None
2012-09-19 Malfunction None Device Displays Incorrect Message
2012-09-17 Malfunction None Device Displays Incorrect Message, Moisture or Humidity Problem
2012-09-17 Malfunction None Device Displays Incorrect Message
2012-09-10 Malfunction None Device Displays Incorrect Message
2012-09-07 Malfunction None Device Displays Incorrect Message
2012-09-04 Malfunction None Device Operates Differently Than Expected
2012-09-04 Malfunction None Failure to Zero, Pressure Problem
2012-08-30 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2012-08-30 Malfunction None Device Displays Incorrect Message
2012-08-30 Malfunction None None
2012-08-30 Malfunction None Electrical /Electronic Property Problem
2012-08-29 Malfunction None Loss of Power, Device Displays Incorrect Message
2012-08-28 Malfunction None Device Inoperable
2012-08-25 Malfunction None None
2012-08-21 Other None Moisture Damage, Improper or Incorrect Procedure or Method, Device Displays Incorrect Message
2012-08-18 Malfunction None None
2012-08-15 Malfunction None Device Operates Differently Than Expected
2012-08-13 Injury None Device Displays Incorrect Message
2012-08-11 Malfunction None None
2012-08-07 Malfunction None Device Operates Differently Than Expected
2012-08-06 Injury None Device Displays Incorrect Message
2012-08-06 Malfunction None None
2012-08-01 Malfunction None Device Alarm System
2012-07-31 Injury None Device Operates Differently Than Expected, Noise, Audible
2012-07-26 Malfunction None None
2012-07-20 Malfunction None None
2012-07-13 Malfunction None Device Operates Differently Than Expected
2012-07-11 Malfunction None Power Problem
2012-07-11 Injury None Device Sensing Problem
2012-07-11 Malfunction None Device Operates Differently Than Expected
2012-07-05 Malfunction None Device Displays Incorrect Message
2012-07-03 Malfunction None None
2012-07-02 Malfunction None Device Displays Incorrect Message
2012-06-26 Malfunction None No Display/Image
2012-06-25 Malfunction None None
2012-06-25 Malfunction None Inability to Auto-Fill
2012-06-22 Malfunction None None
2012-06-21 Malfunction None Device Displays Incorrect Message
2012-06-15 Injury None Failure to Shut Off
2012-06-04 Malfunction None None
2012-06-04 Malfunction None Thermal Decomposition of Device, Device Emits Odor, Loss of Power, Failure to Power Up, Device Displays Incorrect Message, Noise, Audible
2012-06-01 Malfunction None Device Operates Differently Than Expected
2012-06-01 Malfunction None None
2012-05-31 Malfunction None Device Operates Differently Than Expected
2012-05-31 Malfunction None Device Operates Differently Than Expected
2012-05-31 Malfunction None Device Operates Differently Than Expected
2012-05-30 Malfunction None None
2012-05-27 Malfunction None Device Operates Differently Than Expected
2012-05-21 Malfunction None None
2012-05-20 Death None None
2012-05-20 Malfunction None None
2012-05-09 Malfunction None Device Operates Differently Than Expected
2012-04-23 Malfunction None Device Alarm System
2012-04-10 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2012-04-07 Malfunction None None
2012-04-02 Malfunction None Device Operates Differently Than Expected
2012-03-30 Injury None Failure to Read Input Signal, Device Operates Differently Than Expected
2012-03-30 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2012-03-29 Malfunction None Loss of Power
2012-03-23 Malfunction None Device Operates Differently Than Expected
2012-03-22 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2012-03-20 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2012-03-20 Malfunction None None
2012-03-19 Malfunction None Device Operates Differently Than Expected
2012-03-14 Malfunction None Device Operates Differently Than Expected
2012-03-13 Malfunction None Battery Problem, Device Operates Differently Than Expected
2012-03-12 Malfunction None Device Operates Differently Than Expected
2012-03-12 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2012-03-05 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2012-03-01 Death None None
2012-03-01 Malfunction None No Display/Image
2012-02-28 Other None Pumping Stopped, Device Displays Incorrect Message
2012-02-23 Malfunction None Device Operates Differently Than Expected
2012-02-17 Death None None
2012-02-15 Malfunction None Device Displays Incorrect Message
2012-02-01 Malfunction None Device Displays Incorrect Message
2012-02-01 Malfunction None Device Alarm System
2012-01-31 Malfunction None None
2012-01-27 Malfunction None Device Displays Incorrect Message
2012-01-23 Malfunction None None
2011-12-30 Malfunction None Loss of Power, Device Displays Incorrect Message
2011-12-27 Malfunction None Device Operates Differently Than Expected
2011-12-24 Malfunction None None
2011-12-17 Malfunction None None
2011-12-13 Malfunction None None
2011-11-15 Malfunction None Loss of Power
2011-11-08 Malfunction None None
2011-11-08 Malfunction None None
2011-11-01 Malfunction None None
2011-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2011-10-27 Injury None None
2011-10-05 Malfunction None None
2011-10-03 Malfunction None Device Operates Differently Than Expected
2011-10-01 Malfunction None Device Operates Differently Than Expected
2011-09-12 Malfunction None None
2011-09-01 Malfunction None None
2011-08-18 Malfunction None Loss of Power
2011-08-08 Other None None
2011-08-08 Death None None
2011-07-27 Malfunction None Device Operates Differently Than Expected
2011-07-19 Malfunction None Device Displays Incorrect Message
2011-07-18 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-07-17 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-07-16 Malfunction None Device Maintenance Issue, Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-07-08 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-07-04 Malfunction None None
2011-07-03 Malfunction None None
2011-06-28 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected, Device Contamination with Chemical or Other Material
2011-06-27 Malfunction None Device Displays Incorrect Message
2011-06-25 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-23 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-22 Malfunction None None
2011-06-21 Malfunction None Device Displays Incorrect Message
2011-06-21 Malfunction None Device Displays Incorrect Message
2011-06-18 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-17 Malfunction None None
2011-06-17 Malfunction None None
2011-06-16 Malfunction None None
2011-06-13 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-09 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-07 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-02 Malfunction None Device Displays Incorrect Message
2011-05-30 Malfunction None Device Operates Differently Than Expected
2011-05-30 Death None Adverse Event Without Identified Device or Use Problem
2011-05-24 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-05-23 Malfunction None Device Operates Differently Than Expected, Device Contamination with Chemical or Other Material
2011-05-19 Malfunction None Adverse Event Without Identified Device or Use Problem
2011-05-18 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-05-16 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-05-12 Malfunction None Device Displays Incorrect Message
2011-05-11 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-05-10 Malfunction None Power Problem
2011-05-05 Malfunction None No Display/Image, Device Operates Differently Than Expected
2011-05-04 Malfunction None Device Operates Differently Than Expected
2011-05-03 Malfunction None None
2011-05-02 Malfunction None Smoking, Device Operates Differently Than Expected
2011-05-02 Malfunction None None
2011-04-30 Malfunction None Device Displays Incorrect Message
2011-04-29 Malfunction None None
2011-04-29 Malfunction None None
2011-04-26 Malfunction None Device Operates Differently Than Expected
2011-04-26 Malfunction None Device Operates Differently Than Expected
2011-04-21 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-04-18 Malfunction None None
2011-04-15 Malfunction None No Display/Image, Device Operates Differently Than Expected
2011-04-13 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-04-11 Malfunction None Device Displays Incorrect Message, Calibration Problem
2011-04-07 Malfunction None Adverse Event Without Identified Device or Use Problem
2011-04-01 Malfunction None Device Alarm System, Device Operates Differently Than Expected
2011-04-01 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-03-29 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-03-26 Malfunction None Device Operates Differently Than Expected
2011-03-25 Malfunction None None
2011-03-22 Malfunction None Device Operates Differently Than Expected, Device Contamination with Chemical or Other Material
2011-03-21 Malfunction None Device Displays Incorrect Message
2011-03-16 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-03-13 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-03-11 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-03-08 Malfunction None Device Contamination with Body Fluid
2011-03-08 Malfunction None Device Displays Incorrect Message
2011-03-06 Malfunction None None
2011-02-22 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-02-17 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-02-14 Malfunction None None
2011-02-13 Malfunction None None
2011-02-13 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-02-09 Malfunction None None
2011-02-04 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-01-24 Malfunction None Device Contamination with Chemical or Other Material
2011-01-21 Malfunction None Battery Problem, Device Operates Differently Than Expected
2011-01-19 Malfunction None Device Displays Incorrect Message
2011-01-19 Malfunction None Device Operates Differently Than Expected
2011-01-05 Malfunction None Adverse Event Without Identified Device or Use Problem
2011-01-05 Malfunction None Adverse Event Without Identified Device or Use Problem
2011-01-03 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2010-12-30 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2010-12-16 Malfunction None None
2010-12-07 Unknown None None
2010-12-01 Malfunction None None
2010-11-15 Malfunction None None
2010-11-12 Malfunction None None
2010-11-01 Malfunction None None
2010-10-25 Malfunction None None
2010-10-24 Malfunction None None
2010-10-20 Malfunction None None
2010-10-04 Malfunction None None
2010-10-03 Malfunction None None
2010-10-01 Malfunction None None
2010-09-09 Malfunction None None
2010-09-06 Malfunction None None
2010-08-30 Malfunction None None
2010-08-18 Malfunction None None
2010-08-16 Malfunction None None
2010-08-05 Malfunction None None
2010-08-03 Malfunction None None
2010-07-24 Malfunction None None
2010-07-12 Malfunction None None
2010-06-28 Malfunction None None
2010-06-22 Malfunction None None
2010-06-09 Malfunction None None
2010-05-21 Malfunction None None
2010-05-20 Malfunction None None
2010-05-10 Malfunction None None
2010-05-04 Malfunction None None
2010-04-22 Malfunction None None
2010-04-21 Malfunction None None
2010-04-10 Malfunction None None
2010-03-30 Malfunction None None
2010-03-25 Malfunction None None
2010-03-23 Malfunction None None
2010-03-19 Malfunction None None
2010-03-12 Malfunction None None
2010-03-09 Unknown None None
2010-03-03 Malfunction None None
2010-02-06 Malfunction None None
2010-01-27 Malfunction None None
2010-01-22 Malfunction None None
2010-01-22 Malfunction None None
2010-01-20 Malfunction None None
2010-01-18 Malfunction None None
2010-01-12 Malfunction None None
2010-01-05 Malfunction None None
2009-12-21 Malfunction None None
2009-12-17 Malfunction None None
2009-12-12 Malfunction None None
2009-12-11 Malfunction None None
2009-11-08 Malfunction None None
2008-12-29 Malfunction None None