PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DEL

PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

This device is manufactured by MEDTRONIC MINIMED, MEDTRONIC PUERTO RICO OPERATIONS CO.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-02-16 Malfunction No Clinical Signs, Symptoms or Conditions No Display/Image
2024-02-05 Malfunction No Clinical Signs, Symptoms or Conditions Obstruction of Flow
2023-12-08 Malfunction Hyperglycemia, Nausea, Tachycardia, Confusion/ Disorientation None
2023-10-17 Malfunction No Clinical Signs, Symptoms or Conditions Display or Visual Feedback Problem, Failure of Device to Self-Test
2023-10-04 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2023-09-20 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem, Insufficient Information
2023-08-16 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2023-08-03 Malfunction Fatigue, Headache, Hyperglycemia, Muscle Weakness/Atrophy, Vomiting, Malaise Power Problem
2023-08-01 Malfunction No Clinical Signs, Symptoms or Conditions Break
2023-07-10 Malfunction No Clinical Signs, Symptoms or Conditions Visual Prompts will not Clear
2023-07-05 Malfunction No Clinical Signs, Symptoms or Conditions Break, Battery Problem
2023-05-18 Malfunction No Clinical Signs, Symptoms or Conditions Break, Detachment of Device or Device Component
2023-05-15 Malfunction No Clinical Signs, Symptoms or Conditions Material Integrity Problem
2023-04-24 Malfunction No Clinical Signs, Symptoms or Conditions No Display/Image
2023-04-12 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle
2023-03-23 Malfunction No Clinical Signs, Symptoms or Conditions Break
2023-03-08 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2023-03-04 Malfunction No Clinical Signs, Symptoms or Conditions Break, No Display/Image, Mechanical Problem, Device Difficult to Program or Calibrate
2023-02-28 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2023-02-25 Malfunction No Clinical Signs, Symptoms or Conditions Material Integrity Problem
2023-02-03 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle
2023-02-01 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem, Power Problem
2023-01-27 Malfunction No Clinical Signs, Symptoms or Conditions Battery Problem, Material Integrity Problem
2023-01-26 Malfunction Hyperglycemia Insufficient Flow or Under Infusion, Obstruction of Flow
2023-01-24 Malfunction No Clinical Signs, Symptoms or Conditions Detachment of Device or Device Component
2023-01-23 Malfunction No Clinical Signs, Symptoms or Conditions Device Difficult to Program or Calibrate
2023-01-20 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle
2023-01-17 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2023-01-14 Malfunction No Clinical Signs, Symptoms or Conditions Visual Prompts will not Clear
2023-01-08 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle, Detachment of Device or Device Component
2022-12-29 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle
2022-12-28 Malfunction No Clinical Signs, Symptoms or Conditions Material Integrity Problem
2022-12-27 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem, Obstruction of Flow
2022-12-21 Malfunction None Device Alarm System
2022-12-16 Malfunction None Power Problem
2022-12-13 Malfunction None No Display/Image, Material Integrity Problem
2022-12-11 Malfunction None Mechanical Problem, Wireless Communication Problem
2022-12-10 Malfunction No Clinical Signs, Symptoms or Conditions Failure to Cycle, Mechanical Problem, Detachment of Device or Device Component
2022-12-01 Malfunction No Clinical Signs, Symptoms or Conditions No Display/Image, Display or Visual Feedback Problem
2022-11-28 Malfunction Hyperglycemia Break
2022-11-08 Malfunction None Display or Visual Feedback Problem
2022-10-28 Malfunction None Display or Visual Feedback Problem
2022-10-19 Malfunction None Display or Visual Feedback Problem
2022-10-15 Malfunction None Break
2022-10-08 Malfunction None Failure to Cycle
2022-10-07 Malfunction None Display or Visual Feedback Problem
2022-10-06 Malfunction None Failure to Cycle, Mechanical Problem
2022-10-05 Malfunction None No Display/Image
2022-10-05 Injury None Break, No Display/Image, Material Integrity Problem
2022-10-03 Malfunction None Battery Problem
2022-09-28 Malfunction None Visual Prompts will not Clear
2022-09-28 Malfunction None Mechanical Problem
2022-09-19 Malfunction None Failure to Cycle
2022-08-27 Malfunction None Mechanical Problem
2022-08-23 Malfunction None Premature Discharge of Battery, Obstruction of Flow, Loss of Data
2022-08-22 Malfunction None Device Difficult to Program or Calibrate
2022-08-19 Malfunction None Failure to Cycle
2022-08-17 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-08-14 Injury None Device Alarm System, Battery Problem
2022-08-04 Malfunction None Failure to Cycle
2022-08-03 Malfunction None Premature Discharge of Battery, Mechanical Problem
2022-08-01 Malfunction None Failure to Cycle, Mechanical Problem
2022-07-23 Malfunction Hyperglycemia Adverse Event Without Identified Device or Use Problem
2022-07-20 Malfunction None Mechanical Problem
2022-07-19 Malfunction None Break
2022-07-13 Malfunction None Battery Problem
2022-07-12 Injury None Mechanical Problem
2022-07-11 Malfunction None Failure to Cycle
2022-06-27 Malfunction None Failure to Cycle
2022-06-26 Malfunction None Mechanical Problem, Detachment of Device or Device Component
2022-06-25 Malfunction None Failure to Cycle
2022-06-10 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-05-17 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem, Power Problem
2022-05-10 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-05-01 Injury None Mechanical Problem
2022-04-26 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-04-16 Malfunction None Mechanical Problem
2022-04-13 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2022-04-12 Malfunction None Failure to Cycle
2022-04-07 Malfunction None Detachment of Device or Device Component
2022-04-01 Malfunction None Premature Discharge of Battery, Loss of Data
2022-04-01 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-03-31 Malfunction None No Display/Image
2022-03-28 Malfunction None Failure to Cycle
2022-03-26 Malfunction None Device Difficult to Program or Calibrate
2022-03-23 Malfunction None Display or Visual Feedback Problem
2022-03-17 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-03-14 Malfunction None Mechanical Problem, Detachment of Device or Device Component, Failure of Device to Self-Test
2022-02-07 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-01-19 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2022-01-19 Malfunction None Break, Mechanical Problem, Power Problem
2022-01-17 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-01-12 Malfunction No Clinical Signs, Symptoms or Conditions Break
2022-01-10 Malfunction None Break
2021-12-11 Malfunction None Premature Discharge of Battery
2021-12-08 Malfunction None Break
2021-12-01 Malfunction None Mechanical Problem
2021-12-01 Malfunction None Battery Problem
2021-11-22 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-11-10 Malfunction No Clinical Signs, Symptoms or Conditions Power Problem
2021-11-09 Malfunction No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery
2021-11-09 Malfunction None Mechanical Problem
2021-11-08 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-11-08 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-11-07 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-11-03 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-10-14 Malfunction None Break
2021-10-12 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-10-08 Malfunction None Break
2021-10-04 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-10-03 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-09-27 Malfunction None Break, No Display/Image, Material Integrity Problem
2021-09-23 Malfunction No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery
2021-09-14 Malfunction No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery
2021-09-09 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-09-02 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-08-30 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-08-23 Malfunction No Clinical Signs, Symptoms or Conditions Battery Problem
2021-08-17 Malfunction None Battery Problem, Material Integrity Problem
2021-08-16 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-08-11 Malfunction Hyperglycemia Premature Discharge of Battery, Mechanical Problem
2021-08-11 Malfunction None No Display/Image, Material Integrity Problem
2021-08-09 Malfunction No Clinical Signs, Symptoms or Conditions Power Problem
2021-08-08 Malfunction No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery, Loss of Data, Power Problem
2021-07-24 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-07-02 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-06-25 Malfunction No Clinical Signs, Symptoms or Conditions Power Problem
2021-06-21 Malfunction Hyperglycemia Mechanical Problem
2021-06-14 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-06-13 Malfunction None Material Integrity Problem
2021-06-10 Malfunction No Clinical Signs, Symptoms or Conditions Power Problem
2021-06-10 Malfunction None Power Problem
2021-05-25 Malfunction None Break, Material Integrity Problem
2021-05-23 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-05-17 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-05-05 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem, Obstruction of Flow
2021-05-04 Malfunction None Obstruction of Flow
2021-05-04 Malfunction Hypoglycemic Shock Power Problem
2021-05-03 Malfunction None Unexpected Therapeutic Results
2021-04-30 Malfunction None Mechanical Problem, Material Integrity Problem
2021-04-30 Malfunction Hyperglycemia Premature Discharge of Battery, Mechanical Problem, Obstruction of Flow, Loss of Data
2021-04-29 Malfunction None Material Integrity Problem
2021-04-27 Malfunction None Break
2021-04-24 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-04-16 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-04-16 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-03-30 Malfunction None Break
2021-03-21 Malfunction None Material Integrity Problem
2021-03-20 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-03-18 Malfunction None Unexpected Therapeutic Results
2021-03-17 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-03-03 Malfunction No Clinical Signs, Symptoms or Conditions Break
2021-02-23 Malfunction No Clinical Signs, Symptoms or Conditions Battery Problem
2021-02-11 Malfunction No Clinical Signs, Symptoms or Conditions Break, Material Integrity Problem
2021-02-09 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-02-05 Malfunction No Clinical Signs, Symptoms or Conditions Mechanical Problem
2021-02-03 Malfunction No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery, Loss of Data
2020-09-14 Malfunction None Mechanical Problem
2019-09-24 Malfunction None Device Difficult to Program or Calibrate
2019-09-19 Malfunction None Mechanical Problem
2019-09-18 Malfunction None Mechanical Problem
2019-09-17 Malfunction None Mechanical Problem
2019-09-17 Malfunction None Connection Problem, Patient Device Interaction Problem
2019-09-12 Malfunction None Device Difficult to Program or Calibrate
2019-09-11 Malfunction None No Display/Image
2019-09-11 Malfunction None Power Problem
2019-09-10 Malfunction None Premature Discharge of Battery, Device Difficult to Program or Calibrate
2019-09-07 Malfunction None Failure to Cycle
2019-09-07 Malfunction None No Display/Image, Patient Device Interaction Problem
2019-09-06 Malfunction None No Display/Image
2019-09-04 Malfunction None Device Difficult to Program or Calibrate
2019-09-04 Malfunction None Device Alarm System
2019-09-02 Malfunction None Mechanical Problem
2019-09-02 Malfunction None Display or Visual Feedback Problem, Power Problem
2019-09-01 Malfunction None Device Difficult to Program or Calibrate
2019-09-01 Malfunction None Failure to Cycle
2019-09-01 Malfunction None No Display/Image
2019-08-29 Malfunction None Mechanical Problem, Detachment of Device or Device Component
2019-08-29 Malfunction None No Display/Image
2019-08-28 Malfunction None Device Difficult to Program or Calibrate
2019-08-22 Malfunction None Failure to Cycle, Patient Device Interaction Problem
2019-08-21 Malfunction None Device Difficult to Program or Calibrate
2019-08-20 Malfunction None Failure to Cycle, Priming Problem
2019-08-18 Malfunction None No Display/Image, Patient Device Interaction Problem
2019-08-17 Injury None Mechanical Problem, Device Difficult to Program or Calibrate
2019-08-12 Malfunction None Detachment of Device or Device Component
2019-08-09 Malfunction None No Display/Image
2019-08-09 Malfunction None Device Difficult to Program or Calibrate
2019-08-08 Malfunction None Mechanical Problem, Detachment of Device or Device Component
2019-08-07 Malfunction None Device Difficult to Program or Calibrate
2019-08-07 Malfunction None Failure to Cycle
2019-08-02 Malfunction None Mechanical Problem
2019-07-31 Malfunction None Mechanical Problem
2019-07-27 Malfunction None No Display/Image
2019-07-25 Malfunction None No Display/Image
2019-07-25 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-07-23 Malfunction None Device Difficult to Program or Calibrate
2019-07-23 Malfunction None Device Difficult to Program or Calibrate
2019-07-22 Malfunction None Device Difficult to Program or Calibrate
2019-07-21 Malfunction None Power Problem
2019-07-21 Malfunction None No Display/Image
2019-07-20 Malfunction None Device Difficult to Program or Calibrate
2019-07-20 Malfunction None Power Problem
2019-07-16 Malfunction None Device Difficult to Program or Calibrate
2019-07-16 Malfunction None Mechanical Problem
2019-07-10 Malfunction None Mechanical Problem
2019-07-09 Malfunction None Premature Discharge of Battery, No Display/Image
2019-07-09 Malfunction None Device Difficult to Program or Calibrate
2019-07-08 Malfunction None Device Difficult to Program or Calibrate, Power Problem
2019-07-05 Malfunction None Device Difficult to Program or Calibrate
2019-07-03 Malfunction None Device Difficult to Program or Calibrate
2019-07-01 Malfunction None Mechanical Problem, Battery Problem
2019-07-01 Malfunction None Display or Visual Feedback Problem
2019-06-29 Malfunction None Mechanical Problem
2019-06-29 Malfunction None Mechanical Problem, Battery Problem
2019-06-29 Malfunction None Battery Problem, Power Problem
2019-06-26 Malfunction None No Display/Image, Battery Problem, Material Integrity Problem
2019-06-25 Malfunction None No Display/Image
2019-06-25 Malfunction None Mechanical Problem
2019-06-21 Malfunction None Device Alarm System, No Display/Image
2019-06-21 Malfunction None Power Problem
2019-06-21 Malfunction None Failure to Cycle
2019-06-19 Malfunction None No Display/Image, Battery Problem
2019-06-19 Malfunction None Mechanical Problem
2019-06-18 Malfunction None Premature Discharge of Battery
2019-06-17 Malfunction None Computer Software Problem
2019-06-16 Injury None Mechanical Problem
2019-06-13 Malfunction None Mechanical Problem
2019-06-09 Malfunction None No Display/Image
2019-06-08 Malfunction None Mechanical Problem
2019-06-07 Malfunction None Mechanical Problem
2019-06-04 Malfunction None No Display/Image
2019-05-31 Malfunction None No Display/Image
2019-05-31 Malfunction None Device Difficult to Program or Calibrate, Visual Prompts will not Clear
2019-05-30 Malfunction None Device Difficult to Program or Calibrate
2019-05-30 Malfunction None Mechanical Problem
2019-05-29 Malfunction None Mechanical Problem
2019-05-28 Malfunction None No Display/Image, Material Integrity Problem, Power Problem
2019-05-26 Malfunction None No Display/Image
2019-05-23 Malfunction None No Display/Image
2019-05-23 Malfunction None Device Difficult to Program or Calibrate
2019-05-23 Malfunction None Device Difficult to Program or Calibrate
2019-05-23 Malfunction None Mechanical Problem, Appropriate Term/Code Not Available
2019-05-23 Malfunction None Power Problem
2019-05-20 Malfunction None No Display/Image, Battery Problem
2019-05-20 Malfunction None Display or Visual Feedback Problem
2019-05-20 Malfunction None Detachment of Device or Device Component
2019-05-20 Malfunction None Device Difficult to Program or Calibrate
2019-05-19 Malfunction None Battery Problem, Detachment of Device or Device Component
2019-05-18 Malfunction None No Display/Image, Moisture or Humidity Problem
2019-05-17 Malfunction None Device Difficult to Program or Calibrate, Power Problem
2019-05-17 Malfunction None Device Alarm System, Failure of Device to Self-Test
2019-05-15 Malfunction None Device Difficult to Program or Calibrate
2019-05-15 Malfunction None Failure to Cycle
2019-05-14 Malfunction None No Display/Image
2019-05-14 Malfunction None No Display/Image
2019-05-13 Malfunction None Device Difficult to Program or Calibrate
2019-05-12 Malfunction None Mechanical Problem
2019-05-12 Malfunction None No Display/Image
2019-05-09 Malfunction None Device Difficult to Program or Calibrate
2019-05-09 Malfunction None No Display/Image
2019-05-09 Malfunction None Mechanical Problem
2019-05-07 Malfunction None Mechanical Problem
2019-05-06 Malfunction None Device Alarm System
2019-05-05 Malfunction None Device Difficult to Program or Calibrate
2019-05-03 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-05-01 Malfunction None Failure to Cycle
2019-04-29 Malfunction None Power Problem
2019-04-29 Malfunction None Mechanical Problem
2019-04-28 Malfunction None Power Problem
2019-04-22 Malfunction None Mechanical Problem
2019-04-22 Malfunction None Mechanical Problem
2019-04-22 Malfunction None No Display/Image
2019-04-17 Malfunction None Wireless Communication Problem
2019-04-16 Malfunction None Device Alarm System
2019-04-16 Malfunction None Mechanical Problem
2019-04-15 Malfunction None Device Difficult to Program or Calibrate
2019-04-14 Malfunction None Device Alarm System, Device Difficult to Program or Calibrate
2019-04-14 Malfunction None Mechanical Problem
2019-04-11 Malfunction None Mechanical Problem
2019-04-11 Malfunction None Mechanical Problem
2019-04-11 Malfunction None Display or Visual Feedback Problem
2019-04-10 Malfunction None Mechanical Problem
2019-04-10 Malfunction None Mechanical Problem
2019-04-09 Malfunction None Device Alarm System, Device Difficult to Program or Calibrate
2019-04-09 Malfunction None Device Difficult to Program or Calibrate
2019-04-07 Malfunction None Premature Discharge of Battery, No Display/Image, Power Problem, Unexpected Shutdown
2019-04-07 Malfunction None Mechanical Problem
2019-04-07 Malfunction None Mechanical Problem, Power Problem
2019-04-06 Malfunction None Mechanical Problem
2019-04-05 Malfunction None Mechanical Problem
2019-04-04 Malfunction None No Display/Image, Patient Device Interaction Problem
2019-04-03 Injury None Mechanical Problem
2019-04-03 Malfunction None Battery Problem, Power Problem
2019-04-03 Malfunction None Mechanical Problem, Power Problem
2019-04-02 Malfunction None Mechanical Problem
2019-04-01 Malfunction None Mechanical Problem
2019-04-01 Malfunction None Mechanical Problem
2019-03-31 Malfunction None Device Difficult to Program or Calibrate
2019-03-31 Malfunction None Power Problem
2019-03-31 Malfunction None Failure to Cycle
2019-03-30 Malfunction None Device Difficult to Program or Calibrate
2019-03-29 Malfunction None No Display/Image, Display or Visual Feedback Problem
2019-03-28 Malfunction None Detachment of Device or Device Component
2019-03-27 Malfunction None No Display/Image, Patient Device Interaction Problem
2019-03-24 Malfunction None Premature Discharge of Battery, Intermittent Communication Failure
2019-03-24 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-03-22 Malfunction None Failure to Cycle, Mechanical Problem
2019-03-22 Malfunction None Power Problem
2019-03-22 Malfunction None Mechanical Problem
2019-03-21 Malfunction None Mechanical Problem
2019-03-20 Malfunction None Mechanical Problem
2019-03-18 Malfunction None Device Alarm System, Device Difficult to Program or Calibrate
2019-03-17 Malfunction None No Display/Image
2019-03-17 Malfunction None No Display/Image, Mechanical Problem
2019-03-16 Injury None Mechanical Problem
2019-03-15 Malfunction None Device Difficult to Program or Calibrate
2019-03-15 Malfunction None Device Difficult to Program or Calibrate
2019-03-15 Malfunction None Power Problem
2019-03-14 Malfunction None Mechanical Problem
2019-03-14 Malfunction None Premature Discharge of Battery, No Display/Image, Obstruction of Flow
2019-03-14 Malfunction None Mechanical Problem
2019-03-14 Malfunction None Mechanical Problem
2019-03-14 Malfunction None Power Problem, Priming Problem
2019-03-13 Malfunction None Patient Device Interaction Problem
2019-03-12 Malfunction None Device Difficult to Program or Calibrate
2019-03-12 Malfunction None No Display/Image, Power Problem
2019-03-10 Malfunction None Mechanical Problem
2019-03-09 Malfunction None Device Difficult to Program or Calibrate
2019-03-08 Malfunction None No Display/Image
2019-03-05 Malfunction None Mechanical Problem
2019-03-05 Malfunction None Patient Device Interaction Problem
2019-03-03 Malfunction None Mechanical Problem
2019-03-03 Malfunction None Device Difficult to Program or Calibrate
2019-03-01 Malfunction None Mechanical Problem
2019-03-01 Malfunction None Failure to Cycle
2019-03-01 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-03-01 Malfunction None No Display/Image
2019-02-28 Malfunction None No Display/Image
2019-02-28 Malfunction None Device Difficult to Program or Calibrate
2019-02-28 Malfunction None Mechanical Problem
2019-02-27 Malfunction None Mechanical Problem
2019-02-26 Injury None Mechanical Problem
2019-02-24 Malfunction None Failure to Cycle
2019-02-24 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-02-23 Malfunction None Mechanical Problem
2019-02-22 Malfunction None Failure to Cycle
2019-02-22 Malfunction None Power Problem
2019-02-21 Malfunction None Device Difficult to Program or Calibrate
2019-02-21 Malfunction None Mechanical Problem
2019-02-21 Malfunction None Detachment of Device or Device Component
2019-02-21 Malfunction None Mechanical Problem
2019-02-21 Malfunction None Mechanical Problem
2019-02-20 Malfunction None Patient Device Interaction Problem
2019-02-19 Injury None Mechanical Problem
2019-02-18 Malfunction None Mechanical Problem
2019-02-16 Malfunction None Communication or Transmission Problem
2019-02-16 Malfunction None Mechanical Problem
2019-02-15 Malfunction None Device Difficult to Program or Calibrate
2019-02-14 Injury None No Display/Image
2019-02-13 Malfunction None Mechanical Problem, Moisture or Humidity Problem
2019-02-13 Malfunction None Material Integrity Problem
2019-02-12 Malfunction None Mechanical Problem, Adverse Event Without Identified Device or Use Problem
2019-02-12 Malfunction None Mechanical Problem
2019-02-09 Malfunction None Mechanical Problem
2019-02-09 Injury None Mechanical Problem
2019-02-08 Malfunction None Patient Device Interaction Problem
2019-02-08 Malfunction None Device Difficult to Program or Calibrate
2019-02-05 Malfunction None No Display/Image, Patient Device Interaction Problem
2019-02-05 Malfunction None No Display/Image
2019-02-05 Malfunction None Wireless Communication Problem
2019-02-05 Malfunction None Mechanical Problem
2019-02-04 Malfunction None Failure to Cycle
2019-02-01 Malfunction None Failure to Cycle
2019-01-30 Malfunction None Display or Visual Feedback Problem
2019-01-30 Malfunction None Mechanical Problem
2019-01-29 Malfunction None Mechanical Problem
2019-01-28 Malfunction None Premature Discharge of Battery, No Display/Image
2019-01-26 Malfunction None Power Problem
2019-01-26 Malfunction None Loss of Data
2019-01-25 Malfunction None Failure to Cycle
2019-01-23 Malfunction None Device Alarm System
2019-01-22 Malfunction None Mechanical Problem
2019-01-22 Malfunction None Display or Visual Feedback Problem
2019-01-22 Malfunction None Mechanical Problem, Detachment of Device or Device Component
2019-01-19 Injury None Device Difficult to Program or Calibrate
2019-01-17 Injury None Mechanical Problem, Adverse Event Without Identified Device or Use Problem
2019-01-16 Malfunction None Device Difficult to Program or Calibrate
2019-01-14 Malfunction None Insufficient Flow or Under Infusion
2019-01-13 Malfunction None Device Difficult to Program or Calibrate
2019-01-11 Malfunction None Failure to Cycle, Display or Visual Feedback Problem
2019-01-10 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2019-01-10 Malfunction None No Display/Image, Power Problem
2019-01-10 Malfunction None Mechanical Problem
2019-01-10 Malfunction None Mechanical Problem
2019-01-10 Malfunction None Mechanical Problem
2019-01-10 Malfunction None Premature Discharge of Battery, Mechanical Problem, Power Problem
2019-01-09 Malfunction None Mechanical Problem
2019-01-09 Malfunction None Device Difficult to Program or Calibrate, Insufficient Flow or Under Infusion
2019-01-09 Malfunction None Device Difficult to Program or Calibrate
2019-01-08 Malfunction None Device Difficult to Program or Calibrate
2019-01-08 Malfunction None Power Problem
2019-01-07 Malfunction None Mechanical Problem
2019-01-06 Malfunction None Mechanical Problem, Failure of Device to Self-Test
2019-01-05 Injury None Mechanical Problem
2019-01-05 Malfunction None Mechanical Problem
2019-01-04 Malfunction None Device Difficult to Program or Calibrate
2019-01-03 Malfunction None Mechanical Problem
2019-01-03 Malfunction None Mechanical Problem
2019-01-03 Malfunction None Mechanical Problem, Insufficient Flow or Under Infusion
2018-12-30 Malfunction None Power Problem
2018-12-28 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2018-12-28 Malfunction None Failure to Cycle
2018-12-28 Malfunction None No Display/Image
2018-12-27 Malfunction None No Display/Image
2018-12-24 Malfunction None Failure to Cycle, Priming Problem
2018-12-23 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2018-12-22 Injury None Mechanical Problem
2018-12-21 Malfunction None Computer Software Problem
2018-12-19 Malfunction None No Display/Image
2018-12-17 Malfunction None Power Problem
2018-12-17 Malfunction None Mechanical Problem
2018-12-16 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2018-12-14 Malfunction None Mechanical Problem
2018-12-13 Malfunction None Device Difficult to Program or Calibrate, Visual Prompts will not Clear
2018-12-13 Malfunction None Mechanical Problem
2018-12-11 Malfunction None Detachment of Device or Device Component
2018-12-10 Malfunction None Device Difficult to Program or Calibrate
2018-12-10 Malfunction None No Display/Image
2018-12-10 Malfunction None No Display/Image
2018-12-09 Malfunction None Device Difficult to Program or Calibrate
2018-12-08 Malfunction None Failure to Cycle, Mechanical Problem
2018-12-08 Malfunction None No Display/Image
2018-12-07 Malfunction None Priming Problem
2018-12-03 Malfunction None No Display/Image, Mechanical Problem
2018-12-03 Malfunction None Display or Visual Feedback Problem
2018-12-01 Malfunction None Mechanical Problem
2018-11-29 Malfunction None Mechanical Problem
2018-11-28 Malfunction None Mechanical Problem, Device Difficult to Program or Calibrate
2018-11-28 Malfunction None No Display/Image, Power Problem, Patient Device Interaction Problem
2018-11-28 Malfunction None Mechanical Problem
2018-11-26 Malfunction None Power Problem
2018-11-26 Malfunction None Power Problem
2018-11-26 Malfunction None Mechanical Problem
2018-11-25 Malfunction None No Display/Image, Power Problem
2018-11-25 Malfunction None Mechanical Problem
2018-11-24 Malfunction None No Display/Image
2018-11-24 Malfunction None Device Difficult to Program or Calibrate
2018-11-23 Malfunction None Mechanical Problem
2018-11-22 Malfunction None Mechanical Problem
2018-11-21 Malfunction None Failure to Cycle
2018-11-21 Malfunction None Failure to Cycle, Mechanical Problem
2018-11-20 Malfunction None Mechanical Problem
2018-11-19 Malfunction None No Display/Image, Patient Device Interaction Problem
2018-11-19 Malfunction None Mechanical Problem
2018-11-19 Malfunction None Mechanical Problem
2018-11-18 Malfunction None Intermittent Communication Failure
2018-11-16 Malfunction None Detachment of Device or Device Component
2018-11-14 Malfunction None Insufficient Flow or Under Infusion
2018-11-14 Malfunction None Device Difficult to Program or Calibrate
2018-11-14 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2018-11-13 Malfunction None Power Problem
2018-11-12 Injury None Detachment of Device or Device Component
2018-11-12 Malfunction None Mechanical Problem, Adverse Event Without Identified Device or Use Problem
2018-11-11 Injury None Mechanical Problem
2018-11-11 Malfunction None Mechanical Problem, Detachment of Device or Device Component
2018-11-11 Malfunction None Failure to Cycle, Detachment of Device or Device Component
2018-11-09 Malfunction None Mechanical Problem
2018-11-08 Malfunction None No Display/Image
2018-11-08 Malfunction None Mechanical Problem
2018-11-08 Malfunction None No Display/Image
2018-11-07 Malfunction None No Display/Image
2018-11-07 Malfunction None Mechanical Problem, Adverse Event Without Identified Device or Use Problem
2018-11-05 Malfunction None No Display/Image
2018-11-04 Malfunction None Display or Visual Feedback Problem
2018-11-04 Malfunction None Power Problem
2018-11-04 Malfunction None Power Problem
2018-11-04 Malfunction None Display or Visual Feedback Problem
2018-11-04 Malfunction None No Display/Image, Power Problem
2018-11-02 Malfunction None Device Difficult to Program or Calibrate
2018-11-01 Malfunction None Mechanical Problem, Power Problem, No Apparent Adverse Event
2018-10-31 Malfunction None Communication or Transmission Problem, Material Integrity Problem
2018-10-31 Malfunction None Device Difficult to Program or Calibrate
2018-10-29 Malfunction None Mechanical Problem, No Apparent Adverse Event
2018-10-29 Malfunction None Mechanical Problem
2018-10-27 Injury None Failure to Cycle
2018-10-26 Injury None Mechanical Problem
2018-10-24 Malfunction None Device Difficult to Program or Calibrate
2018-10-24 Malfunction None Detachment of Device or Device Component
2018-10-21 Malfunction None Failure to Cycle
2018-10-21 Malfunction None Power Problem
2018-10-21 Malfunction None Power Problem
2018-10-18 Malfunction None Detachment of Device or Device Component
2018-10-17 Injury None Power Problem
2018-10-16 Malfunction None Mechanical Problem
2018-10-16 Injury None Loss of Data
2018-10-16 Malfunction None Display or Visual Feedback Problem
2018-10-15 Malfunction None Mechanical Problem
2018-10-15 Malfunction None Power Problem
2018-10-14 Malfunction None Mechanical Problem
2018-10-12 Malfunction None No Display/Image
2018-10-11 Malfunction None Mechanical Problem
2018-10-11 Malfunction None Premature Discharge of Battery
2018-10-11 Malfunction None Power Problem
2018-10-10 Malfunction None Premature Discharge of Battery
2018-10-09 Malfunction None Mechanical Problem
2018-10-05 Injury None No Display/Image
2018-10-04 Malfunction None Power Problem
2018-10-02 Malfunction None Detachment of Device or Device Component
2018-09-29 Malfunction None Power Problem
2018-09-29 Malfunction None Power Problem
2018-09-27 Malfunction None Intermittent Communication Failure
2018-09-23 Injury None Mechanical Problem
2018-09-23 Malfunction None Insufficient Flow or Under Infusion
2018-09-22 Malfunction None No Display/Image
2018-09-21 Malfunction None Mechanical Problem
2018-09-20 Malfunction None Display or Visual Feedback Problem
2018-09-19 Malfunction None Detachment of Device or Device Component
2018-09-19 Injury None Power Problem
2018-09-18 Malfunction None Display or Visual Feedback Problem
2018-09-18 Malfunction None Mechanical Problem
2018-09-16 Malfunction None Mechanical Problem
2018-09-14 Malfunction None Date/Time-Related Software Problem
2018-09-14 Malfunction None Power Problem
2018-09-11 Malfunction None Failure to Cycle
2018-09-11 Malfunction None Detachment of Device or Device Component
2018-09-11 Malfunction None No Display/Image
2018-09-06 Malfunction None No Display/Image
2018-09-04 Malfunction None Power Problem
2018-09-03 Malfunction None No Display/Image, Device Difficult to Program or Calibrate
2018-08-29 Malfunction None Patient Device Interaction Problem
2018-08-29 Malfunction None Display or Visual Feedback Problem
2018-08-28 Malfunction None Detachment of Device or Device Component
2018-08-28 Malfunction None Device Difficult to Program or Calibrate
2018-08-27 Malfunction None Mechanical Problem
2018-08-27 Malfunction None Appropriate Term/Code Not Available
2018-08-27 Malfunction None Mechanical Problem
2018-08-27 Malfunction None Device Difficult to Program or Calibrate
2018-08-25 Malfunction None Failure to Cycle
2018-08-22 Malfunction None Device Difficult to Program or Calibrate
2018-08-21 Malfunction None No Display/Image
2018-08-21 Malfunction None Power Problem
2018-08-20 Malfunction None Mechanical Problem
2018-08-19 Malfunction None Device Difficult to Program or Calibrate, Obstruction of Flow
2018-08-18 Malfunction None No Display/Image
2018-08-17 Malfunction None Mechanical Problem
2018-08-17 Malfunction None No Display/Image
2018-08-16 Injury None Mechanical Problem
2018-08-14 Malfunction None Mechanical Problem
2018-08-13 Malfunction None Device Difficult to Program or Calibrate
2018-08-08 Malfunction None Detachment of Device or Device Component
2018-08-08 Malfunction None Power Problem
2018-08-08 Malfunction None Mechanical Problem
2018-08-06 Malfunction None Mechanical Problem
2018-08-02 Malfunction None Failure to Cycle
2018-08-01 Malfunction None Device Difficult to Program or Calibrate
2018-07-28 Malfunction None Power Problem
2018-07-26 Malfunction None Appropriate Term/Code Not Available
2018-07-25 Malfunction None Power Problem
2018-07-23 Malfunction None Mechanical Problem
2018-07-21 Malfunction None Device Difficult to Program or Calibrate
2018-07-19 Malfunction None No Display/Image
2018-07-19 Malfunction None Detachment of Device or Device Component, Patient Device Interaction Problem
2018-07-18 Malfunction None Excess Flow or Over-Infusion
2018-07-17 Malfunction None Power Problem
2018-07-17 Malfunction None Device Alarm System
2018-07-17 Malfunction None Failure to Cycle
2018-07-13 Malfunction None Mechanical Problem
2018-07-13 Malfunction None No Display/Image
2018-07-13 Malfunction None No Display/Image
2018-07-11 Malfunction None Power Problem
2018-07-11 Malfunction None Appropriate Term/Code Not Available
2018-07-11 Malfunction None Power Problem
2018-07-08 Injury None Power Problem
2018-07-05 Malfunction None No Display/Image
2018-07-04 Malfunction None Patient Device Interaction Problem
2018-07-01 Malfunction None No Display/Image, Power Problem
2018-06-30 Malfunction None No Display/Image
2018-06-30 Malfunction None Premature Discharge of Battery
2018-06-28 Malfunction None Obstruction of Flow
2018-06-27 Malfunction None Appropriate Term/Code Not Available
2018-06-27 Malfunction None Power Problem
2018-06-26 Malfunction None Human-Device Interface Problem
2018-06-26 Malfunction None Power Problem
2018-06-26 Malfunction None Power Problem
2018-06-25 Malfunction None Power Problem
2018-06-25 Malfunction None Appropriate Term/Code Not Available
2018-06-24 Malfunction None Device Displays Incorrect Message
2018-06-24 Malfunction None Premature Discharge of Battery
2018-06-21 Malfunction None Device Displays Incorrect Message
2018-06-20 Malfunction None Mechanical Problem
2018-06-19 Malfunction None No Display/Image
2018-06-16 Malfunction None No Display/Image
2018-06-16 Malfunction None No Display/Image
2018-06-15 Malfunction None Device Displays Incorrect Message, Battery Problem
2018-06-14 Malfunction None Device Alarm System
2018-06-14 Malfunction None Detachment of Device or Device Component
2018-06-14 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally, Device Inoperable
2018-06-11 Malfunction None Break, Unable to Obtain Readings
2018-06-10 Malfunction None Device Displays Incorrect Message
2018-06-06 Malfunction None Device Alarm System, Device Stops Intermittently
2018-06-05 Malfunction None Device Displays Incorrect Message
2018-06-04 Malfunction None Device Displays Incorrect Message
2018-06-01 Malfunction None Device Difficult to Program or Calibrate
2018-05-28 Malfunction None No Display/Image
2018-05-28 Malfunction None Inaccurate Delivery
2018-05-28 Malfunction None Device Displays Incorrect Message
2018-05-23 Malfunction None No Display/Image
2018-05-21 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2018-05-19 Malfunction None Device Difficult to Program or Calibrate
2018-05-14 Malfunction None Failure to Power Up, Device Inoperable
2018-05-14 Malfunction None Device Displays Incorrect Message, Battery Problem
2018-05-14 Malfunction None Mechanical Problem
2018-05-13 Malfunction None Failure to Power Up
2018-05-13 Injury None Device Displays Incorrect Message
2018-05-13 Malfunction None Device Displays Incorrect Message
2018-05-13 Injury None Mechanical Problem
2018-05-12 Injury None Mechanical Problem, Device Difficult to Program or Calibrate
2018-05-09 Malfunction None Device Displays Incorrect Message, Battery Problem
2018-05-08 Malfunction None No Display/Image, Device Inoperable
2018-05-08 Malfunction None Device Displays Incorrect Message
2018-05-08 Malfunction None Device Displays Incorrect Message
2018-05-07 Malfunction None Mechanical Problem
2018-05-07 Malfunction None Mechanical Problem
2018-05-03 Malfunction None Device Displays Incorrect Message
2018-05-02 Malfunction None Device Inoperable, Device Displays Incorrect Message
2018-05-02 Malfunction None No Display/Image, Noise, Audible
2018-05-02 Malfunction None Device Operates Differently Than Expected
2018-05-01 Malfunction None No Display/Image
2018-04-30 Malfunction None Loose or Intermittent Connection, Device Displays Incorrect Message
2018-04-30 Malfunction None Device Displays Incorrect Message
2018-04-28 Injury None Device Displays Incorrect Message
2018-04-28 Malfunction None Mechanical Problem
2018-04-27 Malfunction None Device Displays Incorrect Message
2018-04-23 Injury None Device Displays Incorrect Message
2018-04-23 Malfunction None No Display/Image, Device Inoperable
2018-04-20 Malfunction None Mechanical Problem
2018-04-19 Malfunction None Device Difficult to Program or Calibrate
2018-04-19 Malfunction None No Display/Image, Device Displays Incorrect Message
2018-04-18 Injury None Low Battery, Device Displays Incorrect Message
2018-04-17 Malfunction None Device Alarm System, Loss of Power
2018-04-16 Malfunction None Device Displays Incorrect Message
2018-04-14 Malfunction None Mechanical Problem
2018-04-13 Malfunction None No Apparent Adverse Event, Appropriate Term/Code Not Available, Patient Device Interaction Problem
2018-04-12 Malfunction None Device Difficult to Program or Calibrate
2018-04-11 Malfunction None Device Displays Incorrect Message
2018-04-11 Malfunction None Device Difficult to Program or Calibrate
2018-04-10 Injury None Device Operates Differently Than Expected
2018-04-09 Malfunction None Bent
2018-04-08 Malfunction None Device Alarm System, No Display/Image, Loss of Power
2018-04-05 Malfunction None Loss of Power, Failure to Power Up
2018-04-04 Malfunction None Device Displays Incorrect Message
2018-04-03 Malfunction None Device Displays Incorrect Message
2018-04-01 Injury None Insufficient Information
2018-04-01 Malfunction None No Display/Image, Failure to Power Up
2018-03-31 Malfunction None Device Displays Incorrect Message
2018-03-27 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2018-03-26 Malfunction None Failure to Power Up
2018-03-26 Malfunction None Power Problem, Patient Device Interaction Problem
2018-03-24 Malfunction None Battery Problem
2018-03-24 Malfunction None Device Difficult to Program or Calibrate
2018-03-22 Malfunction None Mechanical Problem
2018-03-22 Malfunction None Device Displays Incorrect Message
2018-03-22 Malfunction None Device Displays Incorrect Message
2018-03-21 Malfunction None No Display/Image
2018-03-21 Malfunction None No Display/Image
2018-03-21 Malfunction None Device Alarm System
2018-03-21 Malfunction None Device Displays Incorrect Message
2018-03-20 Malfunction None No Display/Image
2018-03-19 Malfunction None Failure to Power Up
2018-03-18 Malfunction None Device Displays Incorrect Message
2018-03-18 Malfunction None Mechanical Problem
2018-03-16 Malfunction None No Display/Image
2018-03-14 Malfunction None Device Displays Incorrect Message
2018-03-14 Injury None Power Problem
2018-03-12 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-03-11 Malfunction None No Display/Image
2018-03-10 Malfunction None Device Displays Incorrect Message, Communication or Transmission Problem
2018-03-09 Malfunction None Mechanical Problem
2018-03-06 Malfunction None Device Displays Incorrect Message
2018-03-02 Malfunction None Crack
2018-03-02 Malfunction None Battery Problem
2018-03-01 Malfunction None No Display/Image, Device Displays Incorrect Message
2018-02-25 Malfunction None Mechanical Problem
2018-02-25 Malfunction None No Display/Image
2018-02-23 Malfunction None Device Difficult to Program or Calibrate
2018-02-22 Malfunction None Mechanical Problem, Patient Device Interaction Problem
2018-02-22 Malfunction None No Display/Image
2018-02-21 Malfunction None Defective Device
2018-02-21 Malfunction None No Display/Image, Loss of Power
2018-02-20 Malfunction None Failure of Device to Self-Test
2018-02-20 Malfunction None Loss of Power, Device Displays Incorrect Message
2018-02-18 Malfunction None Vibration
2018-02-16 Malfunction None No Display/Image, Loss of Power, Failure to Power Up
2018-02-13 Malfunction None Failure to Power Up
2018-02-12 Malfunction None Failure to Power Up
2018-02-12 Malfunction None No Display/Image
2018-02-07 Malfunction None Failure to Power Up
2018-02-03 Malfunction None No Display/Image
2018-02-03 Malfunction None Failure to Power Up
2018-02-01 Injury None Leak/Splash, Loss of Power
2018-02-01 Malfunction None Device Alarm System, Loss of Power
2018-02-01 Malfunction None Device Displays Incorrect Message
2018-01-31 Malfunction None Device Displays Incorrect Message, Battery Problem
2018-01-30 Malfunction None Mechanical Problem
2018-01-29 Malfunction None Device Displays Incorrect Message
2018-01-29 Malfunction None Patient Device Interaction Problem
2018-01-28 Malfunction None Device Alarm System
2018-01-27 Malfunction None Device Displays Incorrect Message
2018-01-26 Malfunction None Device Displays Incorrect Message
2018-01-17 Malfunction None Device Displays Incorrect Message, Material Protrusion/Extrusion
2018-01-17 Malfunction None Device Displays Incorrect Message, Material Protrusion/Extrusion
2018-01-16 Injury None Device Operates Differently Than Expected
2018-01-16 Malfunction None Device Displays Incorrect Message
2018-01-14 Malfunction None Device Difficult to Program or Calibrate
2018-01-11 Malfunction None High Test Results, Device Operates Differently Than Expected
2018-01-11 Malfunction None No Display/Image
2018-01-10 Malfunction None Noise, Audible
2018-01-10 Malfunction None Device Operates Differently Than Expected
2018-01-08 Malfunction None Mechanical Problem
2018-01-07 Malfunction None Device Alarm System
2018-01-06 Malfunction None Insufficient Information
2018-01-06 Malfunction None High Test Results, Device Displays Incorrect Message
2018-01-05 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2018-01-05 Malfunction None Mechanical Problem
2017-12-29 Malfunction None Device Displays Incorrect Message, Inappropriate or Unexpected Reset
2017-12-29 Malfunction None Device Displays Incorrect Message
2017-12-27 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2017-12-26 Malfunction None Loss of Power, Moisture or Humidity Problem, Reset Problem
2017-12-22 Malfunction None Device Alarm System, No Display/Image, Loss of Power, Failure to Power Up
2017-12-19 Malfunction None Mechanical Problem, Power Problem
2017-12-15 Malfunction None Device Displays Incorrect Message
2017-12-13 Malfunction None Device Alarm System, Loss of Power
2017-12-10 Malfunction None Device Inoperable
2017-12-10 Malfunction None Device Displays Incorrect Message
2017-12-09 Malfunction None Device Displays Incorrect Message
2017-12-07 Malfunction None No Display/Image
2017-12-02 Malfunction None Failure to Power Up
2017-12-02 Malfunction None Device Operates Differently Than Expected
2017-12-02 Malfunction None Failure to Power Up, Device Operates Differently Than Expected
2017-11-30 Malfunction None Device Displays Incorrect Message
2017-11-27 Malfunction None No Display/Image
2017-11-26 Malfunction None High Test Results, Low Battery, Device Displays Incorrect Message
2017-11-23 Malfunction None No Display/Image
2017-11-18 Malfunction None Device Displays Incorrect Message
2017-11-18 Malfunction None Battery Problem
2017-11-15 Malfunction None Device Operates Differently Than Expected
2017-11-15 Malfunction None Device Alarm System, Loss of Power
2017-11-11 Malfunction None Failure to Deliver
2017-11-10 Malfunction None Mechanical Problem
2017-11-10 Injury None Device Displays Incorrect Message, Material Protrusion/Extrusion
2017-11-07 Malfunction None Low Battery
2017-11-07 Malfunction None No Display/Image
2017-11-04 Malfunction None Device Operates Differently Than Expected
2017-11-02 Malfunction None Loss of Power
2017-11-02 Malfunction None Device Displays Incorrect Message, Noise, Audible
2017-10-30 Malfunction None Device Inoperable
2017-10-30 Malfunction None Device Stops Intermittently, Device Displays Incorrect Message
2017-10-30 Malfunction None Device Alarm System, Device Stops Intermittently
2017-10-30 Malfunction None No Display/Image
2017-10-28 Malfunction None Device Operates Differently Than Expected
2017-10-28 Malfunction None Device Alarm System, Loss of Power, Battery Problem
2017-10-27 Malfunction None No Display/Image
2017-10-26 Malfunction None Device Displays Incorrect Message
2017-10-25 Malfunction None Loss of Power, Device Displays Incorrect Message
2017-10-23 Malfunction None Break, No Display/Image, Failure to Power Up, Moisture or Humidity Problem
2017-10-23 Malfunction None Mechanical Problem
2017-10-23 Malfunction None Infusion or Flow Problem
2017-10-20 Malfunction None Device Displays Incorrect Message, Failure of Device to Self-Test
2017-10-20 Malfunction None Device Displays Incorrect Message, Material Protrusion/Extrusion
2017-10-19 Malfunction None Device Displays Incorrect Message
2017-10-18 Malfunction None Device Alarm System, No Display/Image, Loss of Power
2017-10-17 Malfunction None Device Alarm System, Loss of Power
2017-10-11 Injury None Device Alarm System, Failure to Prime
2017-10-10 Malfunction None Fluid/Blood Leak
2017-10-08 Malfunction None Device Displays Incorrect Message
2017-10-08 Malfunction None Device Difficult to Program or Calibrate
2017-10-07 Injury None Device Inoperable
2017-09-28 Malfunction None Mechanical Problem, Obstruction of Flow
2017-09-26 Malfunction None Device Displays Incorrect Message
2017-09-25 Malfunction None Failure to Read Input Signal, Device Operates Differently Than Expected
2017-09-23 Injury None Appropriate Term/Code Not Available
2017-09-21 Injury None Thermal Decomposition of Device, Crack, Leak/Splash, Device Displays Incorrect Message
2017-09-20 Malfunction None No Display/Image
2017-09-20 Malfunction None Device Inoperable
2017-09-19 Malfunction None Crack, Device Displays Incorrect Message
2017-09-19 Malfunction None Device Operates Differently Than Expected
2017-09-18 Malfunction None Device Inoperable
2017-09-14 Malfunction None Display or Visual Feedback Problem
2017-09-14 Malfunction None Break
2017-09-14 Malfunction None Defective Device
2017-09-05 Injury None Loss of Power
2017-09-04 Malfunction None Device Displays Incorrect Message
2017-09-04 Malfunction None No Display/Image
2017-09-03 Malfunction None No Display/Image
2017-09-01 Malfunction None No Display/Image, Loss of Power, Device Displays Incorrect Message
2017-09-01 Malfunction None Device Displays Incorrect Message
2017-08-31 Injury None Device Inoperable
2017-08-29 Malfunction None Fluid/Blood Leak, Device Displays Incorrect Message
2017-08-27 Malfunction None Low Battery, Device Displays Incorrect Message
2017-08-17 Malfunction None Device Displays Incorrect Message, Battery Problem
2017-08-15 Malfunction None No Display/Image
2017-08-15 Malfunction None Device Displays Incorrect Message, Positioning Problem
2017-08-14 Malfunction None Optical Discoloration
2017-08-13 Malfunction None Device Alarm System, Device Inoperable
2017-08-12 Malfunction None Device Operates Differently Than Expected
2017-08-07 Malfunction None Break
2017-08-06 Malfunction None Failure to Shut Off
2017-08-04 Malfunction None Loss of Power
2017-08-02 Malfunction None Device Displays Incorrect Message
2017-07-22 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally, Device Displays Incorrect Message
2017-07-20 Malfunction None Display or Visual Feedback Problem, Loss of Power, Device Displays Incorrect Message, Battery Problem
2017-07-10 Malfunction None Device Inoperable, Noise, Audible
2017-07-04 Malfunction None No Display/Image
2017-06-27 Malfunction None No Display/Image
2017-06-26 Malfunction None No Display/Image
2017-06-21 Malfunction None No Display/Image
2017-06-20 Malfunction None Device Displays Incorrect Message
2017-06-20 Malfunction None No Display/Image
2017-06-19 Malfunction None Device Displays Incorrect Message
2017-06-14 Malfunction None No Display/Image
2017-06-12 Malfunction None No Display/Image
2017-06-12 Malfunction None Device Displays Incorrect Message
2017-06-10 Malfunction None Device Displays Incorrect Message
2017-06-09 Malfunction None Device Displays Incorrect Message
2017-06-08 Malfunction None Device Displays Incorrect Message
2017-06-02 Malfunction None Loss of Power
2017-05-29 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2017-05-29 Malfunction None Device Displays Incorrect Message
2017-05-27 Malfunction None No Display/Image
2017-05-26 Malfunction None Device Displays Incorrect Message
2017-05-22 Malfunction None Device Displays Incorrect Message
2017-05-22 Malfunction None No Display/Image
2017-05-19 Malfunction None No Display/Image
2017-05-19 Malfunction None Failure of Device to Self-Test
2017-05-18 Malfunction None Device Inoperable, Vibration
2017-05-15 Malfunction None Device Displays Incorrect Message
2017-05-15 Malfunction None No Display/Image
2017-05-15 Malfunction None Device Displays Incorrect Message
2017-05-12 Malfunction None Break, No Display/Image
2017-05-11 Malfunction None Device Displays Incorrect Message
2017-05-07 Malfunction None No Display/Image
2017-05-04 Malfunction None Device Displays Incorrect Message
2017-05-04 Malfunction None Break, Loose or Intermittent Connection
2017-05-02 Malfunction None No Display/Image
2017-05-01 Malfunction None Device Displays Incorrect Message
2017-04-28 Malfunction None Device Displays Incorrect Message
2017-04-20 Malfunction None Device Operates Differently Than Expected
2017-04-20 Malfunction None No Display/Image
2017-04-19 Malfunction None Device Displays Incorrect Message
2017-04-18 Malfunction None Device Displays Incorrect Message
2017-04-11 Malfunction None Device Displays Incorrect Message
2017-04-09 Malfunction None Device Operates Differently Than Expected
2017-04-08 Malfunction None Break
2017-04-04 Malfunction None Poor Quality Image, Device Displays Incorrect Message
2017-04-02 Malfunction None Device Alarm System
2017-04-02 Malfunction None No Display/Image, Device Displays Incorrect Message
2017-03-30 Malfunction None Inaccurate Delivery
2017-03-29 Malfunction None Computer Software Problem
2017-03-24 Malfunction None No Display/Image
2017-03-24 Malfunction None Device Displays Incorrect Message
2017-03-22 Malfunction None No Display/Image
2017-03-21 Malfunction None Device Operates Differently Than Expected
2017-03-21 Malfunction None No Display/Image
2017-03-20 Malfunction None Failure to Deliver
2017-03-20 Malfunction None Image Display Error/Artifact
2017-03-19 Malfunction None Device Displays Incorrect Message
2017-03-19 Malfunction None No Display/Image
2017-03-17 Malfunction None Device Displays Incorrect Message
2017-03-17 Malfunction None No Display/Image, Device Displays Incorrect Message
2017-03-13 Malfunction None Device Displays Incorrect Message
2017-03-09 Malfunction None No Display/Image
2017-03-07 Malfunction None Device Displays Incorrect Message
2017-03-07 Malfunction None No Display/Image
2017-03-06 Malfunction None No Display/Image
2017-03-05 Malfunction None Device Displays Incorrect Message
2017-03-04 Malfunction None Device Displays Incorrect Message
2017-03-04 Malfunction None Vibration, Defective Component
2017-03-02 Malfunction None Device Operates Differently Than Expected
2017-03-01 Malfunction None Device Operates Differently Than Expected
2017-03-01 Malfunction None No Display/Image
2017-02-28 Malfunction None Device Displays Incorrect Message
2017-02-22 Malfunction None No Display/Image
2017-02-21 Malfunction None No Display/Image
2017-02-19 Malfunction None No Display/Image
2017-02-17 Malfunction None Inaccurate Delivery, Device Displays Incorrect Message
2017-02-17 Malfunction None No Display/Image
2017-02-11 Malfunction None Device Operates Differently Than Expected
2017-02-09 Malfunction None Device Displays Incorrect Message
2017-02-08 Malfunction None No Display/Image
2017-02-07 Malfunction None No Display/Image
2017-02-07 Malfunction None Device Operates Differently Than Expected
2017-02-03 Malfunction None Device Displays Incorrect Message
2017-02-02 Malfunction None No Display/Image
2017-01-30 Malfunction None No Display/Image
2017-01-30 Malfunction None Device Displays Incorrect Message
2017-01-30 Malfunction None Device Operates Differently Than Expected
2017-01-29 Malfunction None Device Displays Incorrect Message
2017-01-21 Malfunction None Power Problem
2017-01-12 Malfunction None Device Operates Differently Than Expected
2017-01-11 Malfunction None Moisture Damage
2017-01-11 Malfunction None Failure to Deliver, Device Displays Incorrect Message
2017-01-09 Malfunction None Device Operates Differently Than Expected
2017-01-07 Malfunction None Device Displays Incorrect Message
2017-01-07 Malfunction None Device Displays Incorrect Message
2017-01-03 Malfunction None Device Displays Incorrect Message
2017-01-03 Malfunction None Loss of Power
2017-01-02 Malfunction None Loss of Power
2017-01-01 Malfunction None Device Displays Incorrect Message
2016-12-28 Malfunction None Device Operates Differently Than Expected
2016-12-17 Malfunction None Device Operates Differently Than Expected
2016-12-09 Malfunction None Device Displays Incorrect Message
2016-12-04 Malfunction None Device Displays Incorrect Message
2016-11-29 Malfunction None No Display/Image, Device Inoperable
2016-11-28 Malfunction None Device Displays Incorrect Message
2016-11-27 Malfunction None Device Displays Incorrect Message
2016-11-27 Malfunction None Application Interface Becomes Non-Functional Or Program Exits Abnormally
2016-11-25 Malfunction None Device Operates Differently Than Expected
2016-11-21 Malfunction None Loss of Power
2016-11-21 Malfunction None Device Operates Differently Than Expected
2016-11-09 Malfunction None Vibration
2016-11-09 Malfunction None Loss of Power
2016-11-09 Malfunction None Device Displays Incorrect Message
2016-11-06 Malfunction None Failure to Prime
2016-11-03 Malfunction None Device Displays Incorrect Message
2016-11-02 Malfunction None Device Displays Incorrect Message
2016-10-29 Malfunction None Device Displays Incorrect Message
2016-10-25 Malfunction None No Display/Image
2016-10-25 Malfunction None Power Problem
2016-10-25 Malfunction None Loss of Power
2016-10-23 Malfunction None No Display/Image
2016-10-21 Malfunction None Device Displays Incorrect Message
2016-10-20 Malfunction None Device Displays Incorrect Message
2016-10-19 Malfunction None Poor Quality Image
2016-10-17 Malfunction None No Display/Image
2016-10-17 Malfunction None Device Displays Incorrect Message
2016-10-13 Malfunction None No Display/Image
2016-10-10 Malfunction None Loss of Power
2016-10-03 Malfunction None Poor Quality Image
2016-09-28 Malfunction None Loss of Power
2016-09-21 Malfunction None Device Displays Incorrect Message
2016-09-19 Malfunction None Failure to Power Up, Device Displays Incorrect Message, Power Problem
2016-09-16 Malfunction None Device Alarm System, Device Displays Incorrect Message
2016-09-15 Malfunction None Device Displays Incorrect Message
2016-09-12 Malfunction None Loss of Power, Failure to Power Up
2016-09-10 Malfunction None Loss of Power
2016-09-08 Malfunction None Loss of Power, Failure to Power Up
2016-09-07 Malfunction None Device Displays Incorrect Message
2016-08-25 Malfunction None Failure to Power Up
2016-08-22 Malfunction None Device Displays Incorrect Message
2016-08-21 Malfunction None Device Displays Incorrect Message
2016-08-16 Malfunction None Failure to Power Up
2016-08-15 Malfunction None Loss of Power, Failure to Power Up
2016-08-15 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2016-08-07 Malfunction None Device Displays Incorrect Message
2016-07-28 Malfunction None Material Discolored, Device Displays Incorrect Message
2016-07-26 Malfunction None Loss of Power, Failure to Power Up, Device Displays Incorrect Message
2016-07-21 Malfunction None Loss of Power, Failure to Power Up, Device Displays Incorrect Message
2016-07-18 Malfunction None Failure to Power Up, Device Displays Incorrect Message, Battery Problem
2016-07-17 Malfunction None Failure to Power Up, Device Displays Incorrect Message, Battery Problem
2016-07-15 Malfunction None Device Displays Incorrect Message
2016-07-15 Malfunction None Device Displays Incorrect Message
2016-07-05 Malfunction None Device Displays Incorrect Message
2016-06-29 Malfunction None Device Displays Incorrect Message
2016-06-28 Malfunction None Device Displays Incorrect Message
2016-06-28 Malfunction None Device Sensing Problem
2016-06-24 Malfunction None Loss of Power, Failure to Power Up
2016-06-24 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2016-06-24 Malfunction None No Display/Image
2016-06-16 Malfunction None Device Displays Incorrect Message
2016-06-10 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2016-06-07 Malfunction None Failure to Deliver
2016-06-07 Malfunction None Device Displays Incorrect Message
2016-06-06 Malfunction None Device Displays Incorrect Message
2016-06-03 Malfunction None Device-Device Incompatibility
2016-06-02 Malfunction None Device-Device Incompatibility
2016-06-01 Malfunction None Communication or Transmission Problem
2016-06-01 Malfunction None Device Displays Incorrect Message
2016-05-26 Malfunction None Loss of Power
2016-05-25 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2016-05-18 Malfunction None Bent, Device Displays Incorrect Message
2016-05-17 Malfunction None Device Displays Incorrect Message
2016-05-17 Malfunction None Device Sensing Problem
2016-05-17 Malfunction None Device Displays Incorrect Message
2016-05-13 Malfunction None Device Displays Incorrect Message
2016-05-11 Malfunction None Device Displays Incorrect Message
2016-05-11 Malfunction None Device Displays Incorrect Message
2016-05-10 Malfunction None Device Displays Incorrect Message
2016-05-09 Malfunction None Device Displays Incorrect Message
2016-05-07 Malfunction None Device Sensing Problem
2016-05-03 Malfunction None Device Displays Incorrect Message
2016-05-01 Malfunction None Loss of Power, Device Displays Incorrect Message
2016-04-29 Malfunction None Loss of Power, Failure to Power Up
2016-04-29 Malfunction None Device Displays Incorrect Message
2016-04-29 Malfunction None Device Displays Incorrect Message
2016-04-22 Malfunction None Device Displays Incorrect Message
2016-04-21 Malfunction None No Display/Image, Component Missing
2016-04-16 Malfunction None Device Operates Differently Than Expected
2016-04-09 Malfunction None Failure to Power Up, Device Displays Incorrect Message
2016-04-05 Malfunction None Failure to Deliver, Device Displays Incorrect Message
2016-04-05 Malfunction None Device Displays Incorrect Message
2016-03-31 Malfunction None Device Displays Incorrect Message
2016-03-30 Malfunction None Device Displays Incorrect Message
2016-03-21 Malfunction None Loss of Power, Failure to Power Up
2016-03-20 Malfunction None Loss of Power, Device Displays Incorrect Message
2016-03-19 Malfunction None Device Displays Incorrect Message
2016-03-16 Malfunction None Corroded, Loss of Power
2016-03-02 Malfunction None Device Inoperable, Device Displays Incorrect Message
2015-05-13 Malfunction None Device Displays Incorrect Message
2015-05-05 Malfunction None Device Inoperable
2015-04-22 Malfunction None No Display/Image
2015-04-10 Malfunction None Insufficient Information
2015-03-27 Malfunction None Device Displays Incorrect Message
2015-03-09 Malfunction None Connection Problem
2015-02-05 Malfunction None Device Alarm System, Device Displays Incorrect Message
2015-02-03 Malfunction None Loss of Power
2015-01-18 Malfunction None Adverse Event Without Identified Device or Use Problem
2014-10-10 Malfunction None Device Displays Incorrect Message
2014-07-17 Malfunction None Mechanical Problem
2014-07-04 Malfunction None Device Displays Incorrect Message