CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
This device is manufactured by TERUMO CARDIOVASCULAR SYSTEMS, TERUMO CARDIOVASCULAR SYSTEMS CORPORATION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-22 | Malfunction | Insufficient Information | Output Problem |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-19 | Malfunction | Insufficient Information | Output Problem |
| 2024-06-17 | Malfunction | Insufficient Information | Output Problem |
| 2024-05-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2024-05-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2024-05-02 | Malfunction | Insufficient Information | Device Alarm System |
| 2024-04-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2024-04-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2024-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Power Problem |
| 2024-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Charging Problem |
| 2024-01-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2024-01-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem, Output Problem |
| 2024-01-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Alarm |
| 2023-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2023-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-12-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2023-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2023-12-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Smoking |
| 2023-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2023-08-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2023-08-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2023-08-01 | Malfunction | Insufficient Information | Output Problem |
| 2023-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Power Problem |
| 2023-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2023-06-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-05-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2023-04-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2023-04-03 | Malfunction | Insufficient Information | Output Problem |
| 2023-03-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2023-03-08 | Malfunction | Insufficient Information | Device Alarm System |
| 2023-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2023-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Output Problem |
| 2023-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Power Up |
| 2023-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2023-01-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2023-01-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Display or Visual Feedback Problem |
| 2022-12-13 | Malfunction | None | Mechanical Problem, Output Problem |
| 2022-12-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Calibration Problem |
| 2022-12-08 | Malfunction | Insufficient Information, No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2022-12-08 | Malfunction | Insufficient Information, No Clinical Signs, Symptoms or Conditions | Device Alarm System |
| 2022-11-23 | Malfunction | None | Device Alarm System |
| 2022-11-17 | Malfunction | None | Device Alarm System, Output Problem |
| 2022-11-09 | Malfunction | None | Power Problem |
| 2022-10-27 | Malfunction | None | False Alarm, Material Deformation |
| 2022-10-21 | Malfunction | None | Device Alarm System, Output Problem |
| 2022-09-29 | Malfunction | None | Pumping Stopped |
| 2022-09-22 | Malfunction | None | Device Alarm System |
| 2022-08-11 | Malfunction | None | Device Alarm System |
| 2022-08-04 | Malfunction | None | Fluid/Blood Leak, Mechanical Problem |
| 2022-07-08 | Malfunction | None | Failure to Power Up |
| 2022-07-07 | Malfunction | None | Output Problem |
| 2022-07-07 | Malfunction | None | Output Problem |
| 2022-07-07 | Malfunction | None | Output Problem |
| 2022-07-06 | Malfunction | None | Mechanical Problem |
| 2022-06-22 | Malfunction | None | Mechanical Problem |
| 2022-05-23 | Malfunction | None | Output Problem |
| 2022-03-16 | Malfunction | None | Device Alarm System |
| 2022-03-08 | Malfunction | None | Mechanical Problem, Output Problem |
| 2022-03-02 | Malfunction | None | Display or Visual Feedback Problem, Pumping Stopped |
| 2022-03-01 | Malfunction | None | Mechanical Problem |
| 2019-10-16 | Malfunction | None | Output Problem |
| 2019-09-05 | Malfunction | None | No Display/Image |
| 2019-08-26 | Malfunction | None | Device Alarm System |
| 2019-08-22 | Malfunction | None | Output Problem |
| 2019-08-22 | Malfunction | None | Fracture |
| 2019-08-21 | Malfunction | None | Connection Problem |
| 2019-08-21 | Malfunction | None | Connection Problem |
| 2019-08-21 | Malfunction | None | Degraded |
| 2019-08-20 | Malfunction | None | Battery Problem |
| 2019-08-19 | Malfunction | None | Failure to Run on Battery |
| 2019-08-19 | Malfunction | None | Output Problem |
| 2019-08-12 | Malfunction | None | Device Sensing Problem |
| 2019-08-12 | Malfunction | None | Failure to Sense |
| 2019-08-08 | Malfunction | None | Increased Pump Speed |
| 2019-08-08 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2019-08-07 | Malfunction | None | Output Problem |
| 2019-08-06 | Malfunction | None | Output Problem |
| 2019-08-06 | Malfunction | None | Unexpected Shutdown |
| 2019-08-02 | Malfunction | None | No Device Output |
| 2019-08-02 | Malfunction | None | Fracture |
| 2019-07-31 | Malfunction | None | Calibration Problem, Output Problem |
| 2019-07-26 | Malfunction | None | Communication or Transmission Problem |
| 2019-07-25 | Malfunction | None | Output Problem |
| 2019-07-25 | Malfunction | None | Failure to Power Up |
| 2019-07-25 | Malfunction | None | Unexpected Shutdown |
| 2019-07-25 | Malfunction | None | Failure to Power Up |
| 2019-07-18 | Malfunction | None | Output Problem |
| 2019-07-18 | Malfunction | None | Output Problem |
| 2019-07-18 | Malfunction | None | Output Problem |
| 2019-07-18 | Malfunction | None | Failure to Power Up |
| 2019-07-18 | Malfunction | None | Output Problem |
| 2019-07-17 | Malfunction | None | Power Problem |
| 2019-07-17 | Malfunction | None | Device Sensing Problem |
| 2019-07-16 | Malfunction | None | Output Problem |
| 2019-07-15 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-07-10 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-07-09 | Malfunction | None | Battery Problem |
| 2019-07-08 | Malfunction | None | Output Problem |
| 2019-07-08 | Malfunction | None | Erratic or Intermittent Display |
| 2019-07-08 | Malfunction | None | Battery Problem |
| 2019-07-04 | Malfunction | None | Output Problem |
| 2019-07-04 | Malfunction | None | Output Problem |
| 2019-07-03 | Malfunction | None | Charging Problem |
| 2019-07-01 | Malfunction | None | Failure to Run on Battery |
| 2019-06-26 | Malfunction | None | Output Problem |
| 2019-06-26 | Malfunction | None | Output Problem |
| 2019-06-26 | Malfunction | None | Battery Problem |
| 2019-06-26 | Malfunction | None | Battery Problem |
| 2019-06-26 | Malfunction | None | Battery Problem |
| 2019-06-24 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-24 | Malfunction | None | Smoking |
| 2019-06-24 | Malfunction | None | No Display/Image |
| 2019-06-19 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-06-18 | Malfunction | None | Battery Problem |
| 2019-06-17 | Malfunction | None | Fracture |
| 2019-06-11 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2019-06-11 | Malfunction | None | Pumping Stopped |
| 2019-06-11 | Malfunction | None | Output Problem |
| 2019-06-10 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-10 | Malfunction | None | Failure to Run on Battery |
| 2019-06-08 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-06-06 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2019-06-05 | Malfunction | None | Battery Problem |
| 2019-06-05 | Malfunction | None | Output Problem |
| 2019-06-03 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-06-01 | Malfunction | None | Battery Problem |
| 2019-05-30 | Malfunction | None | Charging Problem |
| 2019-05-30 | Malfunction | None | Failure to Power Up |
| 2019-05-29 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-05-28 | Malfunction | None | Failure to Power Up |
| 2019-05-23 | Malfunction | None | Mechanical Jam |
| 2019-05-23 | Malfunction | None | Pumping Problem, Noise, Audible |
| 2019-05-21 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2019-05-18 | Malfunction | None | Battery Problem |
| 2019-05-17 | Malfunction | None | Loss of or Failure to Bond |
| 2019-05-15 | Malfunction | None | Battery Problem |
| 2019-05-09 | Malfunction | None | Failure to Power Up |
| 2019-05-07 | Malfunction | None | Output Problem |
| 2019-05-07 | Malfunction | None | Loss of or Failure to Bond |
| 2019-05-05 | Malfunction | None | Output Problem |
| 2019-05-04 | Malfunction | None | Output Problem |
| 2019-05-03 | Malfunction | None | No Display/Image |
| 2019-04-30 | Malfunction | None | Device Slipped |
| 2019-04-29 | Malfunction | None | Output Problem |
| 2019-04-26 | Malfunction | None | Electrical Power Problem |
| 2019-04-26 | Malfunction | None | Break |
| 2019-04-25 | Malfunction | None | False Alarm |
| 2019-04-25 | Malfunction | None | Break |
| 2019-04-25 | Malfunction | None | Mechanical Problem |
| 2019-04-24 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-04-23 | Malfunction | None | Device Alarm System |
| 2019-04-22 | Malfunction | None | Pumping Stopped |
| 2019-04-21 | Malfunction | None | Battery Problem |
| 2019-04-19 | Malfunction | None | Connection Problem |
| 2019-04-18 | Malfunction | None | Battery Problem |
| 2019-04-17 | Malfunction | None | Charging Problem |
| 2019-04-17 | Malfunction | None | Charging Problem |
| 2019-04-17 | Malfunction | None | Charging Problem |
| 2019-04-17 | Malfunction | None | Output Problem |
| 2019-04-16 | Malfunction | None | Charging Problem |
| 2019-04-16 | Malfunction | None | Output Problem |
| 2019-04-16 | Malfunction | None | Charging Problem |
| 2019-04-16 | Malfunction | None | Battery Problem |
| 2019-04-16 | Malfunction | None | Charging Problem |
| 2019-04-15 | Malfunction | None | Charging Problem |
| 2019-04-15 | Malfunction | None | Output Problem |
| 2019-04-15 | Malfunction | None | Charging Problem |
| 2019-04-15 | Malfunction | None | Output Problem |
| 2019-04-15 | Malfunction | None | Output Problem |
| 2019-04-11 | Malfunction | None | False Alarm |
| 2019-04-11 | Malfunction | None | Output Problem |
| 2019-04-09 | Malfunction | None | Output Problem |
| 2019-04-08 | Malfunction | None | Battery Problem |
| 2019-04-04 | Malfunction | None | Material Integrity Problem |
| 2019-04-03 | Malfunction | None | Battery Problem |
| 2019-04-03 | Malfunction | None | Mechanical Problem |
| 2019-04-02 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-04-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-04-01 | Malfunction | None | Mechanical Jam |
| 2019-03-29 | Malfunction | None | Mechanical Jam |
| 2019-03-26 | Malfunction | None | False Alarm |
| 2019-03-21 | Malfunction | None | Output Problem |
| 2019-03-20 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-03-19 | Malfunction | None | Output Problem |
| 2019-03-19 | Malfunction | None | Device Alarm System |
| 2019-03-14 | Malfunction | None | Output Problem |
| 2019-03-14 | Malfunction | None | Battery Problem, Charging Problem |
| 2019-03-13 | Malfunction | None | Pumping Stopped, Output Problem |
| 2019-03-13 | Malfunction | None | Vibration |
| 2019-03-13 | Malfunction | None | Output Problem |
| 2019-03-12 | Malfunction | None | Battery Problem |
| 2019-03-12 | Malfunction | None | Output Problem |
| 2019-03-11 | Malfunction | None | Battery Problem |
| 2019-03-10 | Malfunction | None | Battery Problem |
| 2019-03-08 | Malfunction | None | Power Problem |
| 2019-03-04 | Malfunction | None | Mechanical Problem |
| 2019-03-04 | Malfunction | None | Power Problem |
| 2019-03-01 | Malfunction | None | Mechanical Problem |
| 2019-02-27 | Malfunction | None | Erratic or Intermittent Display |
| 2019-02-27 | Malfunction | None | Pumping Stopped |
| 2019-02-27 | Malfunction | None | Output Problem |
| 2019-02-27 | Malfunction | None | Pumping Stopped |
| 2019-02-27 | Malfunction | None | Charging Problem |
| 2019-02-26 | Malfunction | None | Output Problem |
| 2019-02-26 | Malfunction | None | Charging Problem |
| 2019-02-26 | Malfunction | None | Charging Problem |
| 2019-02-25 | Malfunction | None | Charging Problem |
| 2019-02-21 | Malfunction | None | Device Alarm System |
| 2019-02-21 | Malfunction | None | Battery Problem |
| 2019-02-21 | Malfunction | None | Material Erosion |
| 2019-02-20 | Malfunction | None | Battery Problem |
| 2019-02-14 | Malfunction | None | No Display/Image |
| 2019-02-13 | Malfunction | None | Charging Problem |
| 2019-02-11 | Malfunction | None | Break |
| 2019-02-08 | Malfunction | None | Pumping Stopped |
| 2019-02-08 | Malfunction | None | Break |
| 2019-02-08 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-02-08 | Malfunction | None | Pumping Stopped |
| 2019-02-07 | Malfunction | None | False Alarm |
| 2019-02-06 | Malfunction | None | Battery Problem |
| 2019-02-06 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-02-05 | Malfunction | None | Charging Problem |
| 2019-02-05 | Malfunction | None | Charging Problem |
| 2019-02-04 | Malfunction | None | Device Alarm System |
| 2019-02-04 | Malfunction | None | Increased Pump Speed |
| 2019-02-04 | Malfunction | None | Mechanical Jam |
| 2019-02-04 | Malfunction | None | Connection Problem |
| 2019-02-02 | Malfunction | None | Device Alarm System |
| 2019-01-31 | Malfunction | None | Battery Problem |
| 2019-01-31 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-31 | Malfunction | None | No Display/Image |
| 2019-01-28 | Malfunction | None | Battery Problem |
| 2019-01-24 | Malfunction | None | Output Problem |
| 2019-01-23 | Malfunction | None | Device Sensing Problem |
| 2019-01-23 | Malfunction | None | Charging Problem |
| 2019-01-23 | Malfunction | None | Failure to Calibrate |
| 2019-01-17 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-01-17 | Malfunction | None | Electrical /Electronic Property Problem |
| 2019-01-15 | Malfunction | None | Battery Problem |
| 2019-01-15 | Malfunction | None | Connection Problem |
| 2019-01-14 | Malfunction | None | Charging Problem |
| 2019-01-14 | Malfunction | None | Unable to Obtain Readings |
| 2019-01-12 | Malfunction | None | Charging Problem |
| 2019-01-10 | Malfunction | None | Charging Problem |
| 2019-01-10 | Malfunction | None | Mechanical Problem |
| 2019-01-07 | Malfunction | None | Loss of Power, Battery Problem |
| 2019-01-07 | Malfunction | None | Battery Problem |
| 2019-01-04 | Malfunction | None | Erratic or Intermittent Display |
| 2018-12-31 | Malfunction | None | Battery Problem |
| 2018-12-30 | Malfunction | None | Break, Electrical /Electronic Property Problem |
| 2018-12-27 | Malfunction | None | Pumping Stopped |
| 2018-12-26 | Malfunction | None | Pumping Stopped |
| 2018-12-21 | Malfunction | None | Battery Problem |
| 2018-12-19 | Malfunction | None | Mechanical Jam |
| 2018-12-19 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-18 | Malfunction | None | Device Sensing Problem |
| 2018-12-18 | Malfunction | None | Power Problem |
| 2018-12-17 | Malfunction | None | Output Problem |
| 2018-12-16 | Malfunction | None | Output Problem |
| 2018-12-15 | Malfunction | None | Output Problem |
| 2018-12-14 | Malfunction | None | Power Problem |
| 2018-12-14 | Malfunction | None | Pumping Stopped |
| 2018-12-13 | Malfunction | None | Physical Resistance/Sticking |
| 2018-12-13 | Malfunction | None | Charging Problem, Output Problem |
| 2018-12-12 | Malfunction | None | Pumping Stopped |
| 2018-12-10 | Malfunction | None | No Flow |
| 2018-12-08 | Malfunction | None | Charging Problem |
| 2018-12-07 | Malfunction | None | Pumping Stopped |
| 2018-12-06 | Malfunction | None | Output Problem |
| 2018-12-06 | Malfunction | None | Pumping Stopped |
| 2018-12-04 | Malfunction | None | Charging Problem |
| 2018-12-04 | Malfunction | None | Connection Problem |
| 2018-12-03 | Malfunction | None | False Alarm |
| 2018-12-03 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-11-27 | Malfunction | None | Failure to Charge |
| 2018-11-27 | Malfunction | None | Unexpected Shutdown |
| 2018-11-17 | Malfunction | None | Output Problem |
| 2018-11-16 | Malfunction | None | Charging Problem |
| 2018-11-16 | Malfunction | None | Failure to Calibrate |
| 2018-11-16 | Malfunction | None | No Display/Image |
| 2018-11-16 | Malfunction | None | Mechanical Jam |
| 2018-11-16 | Malfunction | None | No Display/Image |
| 2018-11-12 | Malfunction | None | Charging Problem |
| 2018-11-10 | Malfunction | None | Output Problem |
| 2018-11-09 | Malfunction | None | Mechanical Problem |
| 2018-11-08 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-11-05 | Malfunction | None | Charging Problem |
| 2018-11-01 | Malfunction | None | Pumping Stopped |
| 2018-10-31 | Malfunction | None | Charging Problem |
| 2018-10-29 | Malfunction | None | Break |
| 2018-10-29 | Malfunction | None | Loose or Intermittent Connection |
| 2018-10-26 | Malfunction | None | Battery Problem |
| 2018-10-25 | Malfunction | None | Erratic or Intermittent Display |
| 2018-10-23 | Malfunction | None | Material Twisted/Bent |
| 2018-10-23 | Malfunction | None | Output Problem |
| 2018-10-23 | Malfunction | None | Mechanical Problem |
| 2018-10-23 | Malfunction | None | Mechanical Problem |
| 2018-10-18 | Malfunction | None | Connection Problem |
| 2018-10-18 | Malfunction | None | Gas Output Problem |
| 2018-10-17 | Malfunction | None | False Alarm, Unexpected Shutdown |
| 2018-10-17 | Malfunction | None | Charging Problem |
| 2018-10-15 | Malfunction | None | False Alarm |
| 2018-10-11 | Malfunction | None | Communication or Transmission Problem |
| 2018-10-11 | Malfunction | None | Pumping Stopped |
| 2018-10-11 | Malfunction | None | Communication or Transmission Problem |
| 2018-10-09 | Malfunction | None | Battery Problem |
| 2018-10-04 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-10-03 | Malfunction | None | Smoking |
| 2018-10-02 | Malfunction | None | Output Problem |
| 2018-09-20 | Malfunction | None | Device Alarm System |
| 2018-09-19 | Malfunction | None | Battery Problem |
| 2018-09-17 | Malfunction | None | Intermittent Communication Failure |
| 2018-09-17 | Malfunction | None | Device Alarm System |
| 2018-09-15 | Malfunction | None | Output Problem |
| 2018-09-13 | Malfunction | None | Output Problem |
| 2018-09-11 | Malfunction | None | Communication or Transmission Problem |
| 2018-09-11 | Malfunction | None | Connection Problem |
| 2018-09-07 | Malfunction | None | Charging Problem |
| 2018-09-06 | Malfunction | None | Charging Problem |
| 2018-09-05 | Malfunction | None | Battery Problem |
| 2018-09-05 | Malfunction | None | Failure to Charge |
| 2018-08-31 | Malfunction | None | Device Alarm System |
| 2018-08-30 | Malfunction | None | Charging Problem |
| 2018-08-30 | Malfunction | None | Failure to Power Up |
| 2018-08-24 | Malfunction | None | Output Problem |
| 2018-08-23 | Malfunction | None | Battery Problem |
| 2018-08-22 | Malfunction | None | Mechanical Problem |
| 2018-08-21 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-08-16 | Malfunction | None | Break |
| 2018-08-16 | Malfunction | None | Device Alarm System |
| 2018-08-09 | Malfunction | None | Charging Problem |
| 2018-08-08 | Malfunction | None | Charging Problem |
| 2018-08-08 | Malfunction | None | Charging Problem |
| 2018-08-06 | Malfunction | None | Output Problem |
| 2018-08-01 | Malfunction | None | Device Displays Incorrect Message |
| 2018-07-30 | Malfunction | None | Material Integrity Problem |
| 2018-07-30 | Malfunction | None | Battery Problem |
| 2018-07-30 | Malfunction | None | Device Alarm System |
| 2018-07-30 | Malfunction | None | Battery Problem |
| 2018-07-26 | Malfunction | None | Communication or Transmission Problem |
| 2018-07-24 | Malfunction | None | Incorrect Measurement |
| 2018-07-23 | Malfunction | None | Intermittent Loss of Power |
| 2018-07-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-07-20 | Malfunction | None | Display or Visual Feedback Problem |
| 2018-07-20 | Malfunction | None | Output Problem |
| 2018-07-18 | Malfunction | None | Overheating of Device, Electrical Shorting |
| 2018-07-18 | Malfunction | None | Display Difficult to Read |
| 2018-07-18 | Malfunction | None | False Alarm |
| 2018-07-17 | Malfunction | None | Failure to Charge, Battery Problem |
| 2018-07-17 | Malfunction | None | Charging Problem |
| 2018-07-17 | Malfunction | None | Device Emits Odor, Smoking, Noise, Audible |
| 2018-07-16 | Malfunction | None | Device Sensing Problem |
| 2018-07-13 | Malfunction | None | Failure to Charge |
| 2018-07-12 | Malfunction | None | Battery Problem |
| 2018-07-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-07-12 | Malfunction | None | Battery Problem |
| 2018-07-09 | Malfunction | None | Failure to Calibrate, No Tactile Prompts/Feedback |
| 2018-07-07 | Malfunction | None | Battery Problem |
| 2018-07-06 | Malfunction | None | Power Problem |
| 2018-07-05 | Malfunction | None | Battery Problem |
| 2018-07-02 | Malfunction | None | Device Displays Incorrect Message |
| 2018-07-02 | Malfunction | None | Device Alarm System |
| 2018-07-02 | Malfunction | None | Battery Problem |
| 2018-06-29 | Malfunction | None | Display Difficult to Read |
| 2018-06-28 | Malfunction | None | False Alarm |
| 2018-06-26 | Malfunction | None | No Display/Image |
| 2018-06-26 | Malfunction | None | Battery Problem |
| 2018-06-21 | Malfunction | None | Connection Problem |
| 2018-06-20 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-18 | Malfunction | None | Computer Operating System Problem |
| 2018-06-18 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-18 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-16 | Malfunction | None | Failure to Run on Battery, Connection Problem |
| 2018-06-15 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-06-14 | Malfunction | None | Battery Problem |
| 2018-06-14 | Malfunction | None | Activation Problem |
| 2018-06-14 | Malfunction | None | Battery Problem |
| 2018-06-13 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-06-12 | Malfunction | None | Erratic or Intermittent Display |
| 2018-06-11 | Malfunction | None | Power Problem |
| 2018-06-11 | Malfunction | None | Battery Problem |
| 2018-06-07 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-07 | Malfunction | None | Battery Problem |
| 2018-06-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-06-05 | Malfunction | None | Battery Problem |
| 2018-06-04 | Malfunction | None | Battery Problem |
| 2018-05-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-31 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-30 | Malfunction | None | Battery Problem |
| 2018-05-30 | Malfunction | None | Battery Problem |
| 2018-05-30 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-29 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-25 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-05-18 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-14 | Malfunction | None | Battery Problem |
| 2018-05-11 | Malfunction | None | Mechanical Jam |
| 2018-05-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-11 | Malfunction | None | No Display/Image |
| 2018-05-09 | Malfunction | None | No Display/Image |
| 2018-05-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-07 | Malfunction | None | Battery Problem |
| 2018-05-07 | Malfunction | None | Battery Problem |
| 2018-05-04 | Malfunction | None | Fracture |
| 2018-05-02 | Malfunction | None | Failure to Charge, Battery Problem |
| 2018-05-02 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-01 | Malfunction | None | Battery Problem |
| 2018-05-01 | Malfunction | None | Out-Of-Box Failure, Calibration Problem |
| 2018-04-30 | Malfunction | None | Pumping Stopped |
| 2018-04-30 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-04-27 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-04-26 | Malfunction | None | Device Displays Incorrect Message, Connection Problem |
| 2018-04-25 | Malfunction | None | Battery Problem |
| 2018-04-25 | Malfunction | None | Out-Of-Box Failure, Device Displays Incorrect Message |
| 2018-04-24 | Malfunction | None | Out-Of-Box Failure, Failure to Calibrate |
| 2018-04-19 | Malfunction | None | Device Displays Incorrect Message |
| 2018-04-18 | Malfunction | None | Battery Problem |
| 2018-04-18 | Malfunction | None | No Display/Image |
| 2018-04-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-15 | Malfunction | None | Failure to Power Up |
| 2018-04-12 | Malfunction | None | Device Alarm System |
| 2018-04-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-04 | Malfunction | None | Battery Problem |
| 2018-04-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-30 | Malfunction | None | Device Alarm System |
| 2018-03-29 | Malfunction | None | Pumping Stopped |
| 2018-03-24 | Malfunction | None | Battery Problem |
| 2018-03-21 | Malfunction | None | Pumping Stopped |
| 2018-03-20 | Malfunction | None | No Display/Image |
| 2018-03-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-15 | Malfunction | None | Failure to Calibrate, Device Operates Differently Than Expected |
| 2018-03-15 | Malfunction | None | Maintenance Does Not Comply To Manufacturers Recommendations |
| 2018-03-14 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-14 | Malfunction | None | Battery Problem |
| 2018-03-14 | Malfunction | None | Battery Problem |
| 2018-03-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-13 | Malfunction | None | Low Battery |
| 2018-03-12 | Malfunction | None | No Display/Image |
| 2018-03-11 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-09 | Malfunction | None | Gas Output Problem, Out-Of-Box Failure |
| 2018-03-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-06 | Malfunction | None | Charging Problem |
| 2018-03-06 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-05 | Malfunction | None | Charging Problem |
| 2018-02-28 | Malfunction | None | Failure To Adhere Or Bond |
| 2018-02-24 | Malfunction | None | Erratic or Intermittent Display |
| 2018-02-23 | Malfunction | None | Device Alarm System |
| 2018-02-22 | Malfunction | None | Device Displays Incorrect Message, Battery Problem |
| 2018-02-21 | Malfunction | None | Device Displays Incorrect Message |
| 2018-02-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-19 | Malfunction | None | No Display/Image |
| 2018-02-19 | Malfunction | None | No Display/Image |
| 2018-02-17 | Malfunction | None | Power Problem |
| 2018-02-16 | Malfunction | None | Out-Of-Box Failure, Failure to Calibrate |
| 2018-02-16 | Malfunction | None | Fluid/Blood Leak, Pumping Stopped |
| 2018-02-15 | Malfunction | None | Fracture |
| 2018-02-15 | Malfunction | None | Decreased Pump Speed, Device Operates Differently Than Expected |
| 2018-02-14 | Malfunction | None | Leak/Splash, Pumping Stopped |
| 2018-02-13 | Malfunction | None | Failure To Adhere Or Bond |
| 2018-02-13 | Malfunction | None | Failure To Adhere Or Bond |
| 2018-02-13 | Malfunction | None | Fracture |
| 2018-02-12 | Malfunction | None | Battery Problem |
| 2018-02-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-09 | Malfunction | None | Battery Problem |
| 2018-02-09 | Malfunction | None | Device Alarm System |
| 2018-02-09 | Malfunction | None | Failure To Adhere Or Bond |
| 2018-02-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-08 | Malfunction | None | Device Displays Incorrect Message |
| 2018-02-05 | Malfunction | None | Erratic or Intermittent Display |
| 2018-02-05 | Malfunction | None | Leak/Splash, Device Displays Incorrect Message |
| 2018-02-02 | Malfunction | None | Break |
| 2018-01-31 | Malfunction | None | Battery Problem |
| 2018-01-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-29 | Malfunction | None | Corroded, Device Displays Incorrect Message |
| 2018-01-29 | Malfunction | None | Power Problem |
| 2018-01-28 | Malfunction | None | No Display/Image |
| 2018-01-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-24 | Malfunction | None | Battery Problem |
| 2018-01-22 | Malfunction | None | Failure To Adhere Or Bond, Out-Of-Box Failure |
| 2018-01-19 | Malfunction | None | Battery Problem |
| 2018-01-18 | Malfunction | None | Device Displays Incorrect Message |
| 2018-01-18 | Malfunction | None | Failure To Adhere Or Bond |
| 2018-01-17 | Malfunction | None | Pumping Stopped |
| 2018-01-16 | Malfunction | None | Device Displays Incorrect Message |
| 2018-01-15 | Malfunction | None | False Alarm |
| 2018-01-12 | Malfunction | None | Device Alarm System, Device Displays Incorrect Message |
| 2018-01-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-11 | Malfunction | None | Device Alarm System |
| 2018-01-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-10 | Malfunction | None | Charging Problem |
| 2018-01-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-09 | Malfunction | None | Gas Output Problem |
| 2018-01-07 | Malfunction | None | Corroded |
| 2018-01-04 | Malfunction | None | Device Displays Incorrect Message |
| 2018-01-03 | Malfunction | None | Material Frayed |
| 2018-01-03 | Malfunction | None | Device Alarm System |
| 2018-01-03 | Malfunction | None | Battery Problem |
| 2018-01-02 | Malfunction | None | No Display/Image |
| 2018-01-02 | Malfunction | None | Erratic or Intermittent Display |
| 2018-01-02 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-28 | Malfunction | None | Failure to Charge |
| 2017-12-28 | Malfunction | None | No Display/Image |
| 2017-12-28 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-26 | Malfunction | None | No Display/Image |
| 2017-12-25 | Malfunction | None | No Display/Image |
| 2017-12-20 | Malfunction | None | Pumping Stopped |
| 2017-12-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-20 | Malfunction | None | No Display/Image |
| 2017-12-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-19 | Malfunction | None | Erratic or Intermittent Display |
| 2017-12-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-16 | Malfunction | None | Battery Problem |
| 2017-12-15 | Malfunction | None | Disconnection, Charging Problem |
| 2017-12-13 | Malfunction | None | Pumping Stopped |
| 2017-12-11 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-08 | Malfunction | None | High impedance, Out-Of-Box Failure |
| 2017-12-06 | Malfunction | None | Pumping Stopped |
| 2017-12-06 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-05 | Malfunction | None | Device Alarm System |
| 2017-12-04 | Malfunction | None | Communication or Transmission Problem |
| 2017-12-04 | Malfunction | None | Pumping Stopped |
| 2017-12-04 | Malfunction | None | Communication or Transmission Problem |
| 2017-11-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-30 | Malfunction | None | Charging Problem |
| 2017-11-28 | Malfunction | None | Loss of Power, Device Displays Incorrect Message |
| 2017-11-27 | Malfunction | None | Power Problem |
| 2017-11-27 | Injury | None | Pumping Stopped |
| 2017-11-24 | Malfunction | None | No Display/Image |
| 2017-11-22 | Malfunction | None | Thermal Decomposition of Device |
| 2017-11-20 | Malfunction | None | Pumping Stopped, Device Displays Incorrect Message |
| 2017-11-17 | Malfunction | None | Degraded, Battery Problem |
| 2017-11-16 | Malfunction | None | Connection Problem |
| 2017-11-16 | Malfunction | None | Battery Problem |
| 2017-11-16 | Malfunction | None | Pumping Stopped, Device Displays Incorrect Message |
| 2017-11-15 | Malfunction | None | Power Problem |
| 2017-11-14 | Malfunction | None | Failure to Sense |
| 2017-11-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-07 | Malfunction | None | No Display/Image, Device Inoperable |
| 2017-11-07 | Malfunction | None | Charging Problem |
| 2017-10-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-27 | Malfunction | None | False Alarm |
| 2017-10-24 | Malfunction | None | Pumping Stopped |
| 2017-10-21 | Malfunction | None | Pumping Stopped |
| 2017-10-17 | Malfunction | None | Image Display Error/Artifact |
| 2017-10-17 | Malfunction | None | Failure To Adhere Or Bond |
| 2017-10-17 | Malfunction | None | Device Displays Incorrect Message |
| 2017-10-15 | Malfunction | None | Pumping Stopped, Device Displays Incorrect Message |
| 2017-10-15 | Malfunction | None | Erratic or Intermittent Display |
| 2017-10-13 | Malfunction | None | Component Missing |
| 2017-10-12 | Malfunction | None | Battery Problem |
| 2017-10-12 | Malfunction | None | Pumping Stopped |
| 2017-10-11 | Malfunction | None | Device Displays Incorrect Message |
| 2017-10-11 | Malfunction | None | Battery Problem |
| 2017-10-06 | Malfunction | None | Device Displays Incorrect Message, Power Problem |
| 2017-10-06 | Malfunction | None | Bent, Fracture, Mechanical Jam |
| 2017-10-06 | Malfunction | None | Failure To Adhere Or Bond |
| 2017-10-05 | Malfunction | None | Device Stops Intermittently, Device Displays Incorrect Message |
| 2017-09-29 | Malfunction | None | Erratic or Intermittent Display |
| 2017-09-27 | Malfunction | None | Communication or Transmission Problem |
| 2017-09-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-25 | Malfunction | None | Communication or Transmission Problem |
| 2017-09-21 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-20 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-19 | Malfunction | None | Low Battery |
| 2017-09-19 | Malfunction | None | Device Operates Differently Than Expected, Material Integrity Problem |
| 2017-09-19 | Malfunction | None | Failure To Adhere Or Bond |
| 2017-09-18 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-18 | Malfunction | None | Failure To Adhere Or Bond |
| 2017-09-15 | Malfunction | None | No Display/Image |
| 2017-09-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-12 | Malfunction | None | Impedance Problem |
| 2017-09-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-08 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-09-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-01 | Malfunction | None | Fracture |
| 2017-08-30 | Malfunction | None | No Display/Image |
| 2017-08-25 | Malfunction | None | Device Displays Incorrect Message, Connection Problem |
| 2017-08-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-22 | Malfunction | None | Device Alarm System, Device Displays Incorrect Message |
| 2017-08-18 | Malfunction | None | Fracture |
| 2017-08-17 | Malfunction | None | Mechanical Jam, Noise, Audible |
| 2017-08-17 | Malfunction | None | Sparking |
| 2017-08-17 | Malfunction | None | Battery Problem |
| 2017-08-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-14 | Malfunction | None | Fracture |
| 2017-08-07 | Malfunction | None | Device Alarm System, Device Operates Differently Than Expected |
| 2017-08-07 | Malfunction | None | No Display/Image, Device Operates Differently Than Expected |
| 2017-08-03 | Malfunction | None | Device Operates Differently Than Expected, Maintenance Does Not Comply To Manufacturers Recommendations |
| 2017-08-03 | Malfunction | None | Device Alarm System |
| 2017-08-02 | Malfunction | None | Material Integrity Problem |
| 2017-07-28 | Malfunction | None | Leak/Splash, Out-Of-Box Failure |
| 2017-07-27 | Malfunction | None | No Display/Image |
| 2017-07-26 | Malfunction | None | Device Displays Incorrect Message, Pumping Problem |
| 2017-07-25 | Malfunction | None | Pumping Problem |
| 2017-07-24 | Malfunction | None | Out-Of-Box Failure, Improper Device Output |
| 2017-07-24 | Malfunction | None | Out-Of-Box Failure, Improper Device Output |
| 2017-07-18 | Malfunction | None | Difficult to Open or Close |
| 2017-07-17 | Malfunction | None | Device Alarm System |
| 2017-07-17 | Malfunction | None | Output Problem |
| 2017-07-14 | Malfunction | None | No Display/Image |
| 2017-07-12 | Malfunction | None | No Display/Image |
| 2017-07-11 | Malfunction | None | Device Displays Incorrect Message |
| 2017-07-11 | Malfunction | None | Crack, Device Operates Differently Than Expected |
| 2017-07-10 | Malfunction | None | Device Displays Incorrect Message |
| 2017-07-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-07-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-29 | Malfunction | None | Fracture |
| 2017-06-29 | Malfunction | None | False Alarm |
| 2017-06-27 | Malfunction | None | Device Alarm System |
| 2017-06-26 | Malfunction | None | No Display/Image |
| 2017-06-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-21 | Malfunction | None | Pumping Problem |
| 2017-06-20 | Malfunction | None | No Display/Image |
| 2017-06-16 | Malfunction | None | Pumping Stopped |
| 2017-06-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-14 | Malfunction | None | Device Alarm System, Device Operates Differently Than Expected |
| 2017-06-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-09 | Malfunction | None | Device Displays Incorrect Message |
| 2017-06-07 | Malfunction | None | Erratic or Intermittent Display |
| 2017-06-06 | Malfunction | None | Mechanical Jam |
| 2017-06-02 | Malfunction | None | No Display/Image, Smoking, Device Inoperable |
| 2017-05-31 | Malfunction | None | No Display/Image |
| 2017-05-31 | Malfunction | None | Device Displays Incorrect Message, Power Problem |
| 2017-05-31 | Malfunction | None | Failure to Calibrate |
| 2017-05-29 | Malfunction | None | Break |
| 2017-05-23 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-05-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-20 | Malfunction | None | Device Displays Incorrect Message |
| 2017-05-19 | Malfunction | None | Break |
| 2017-05-18 | Malfunction | None | Break |
| 2017-05-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-17 | Malfunction | None | Break |
| 2017-05-15 | Malfunction | None | Device Alarm System, Device Operates Differently Than Expected |
| 2017-05-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-26 | Malfunction | None | Device Displays Incorrect Message |
| 2017-04-26 | Malfunction | None | Device Displays Incorrect Message |
| 2017-04-26 | Malfunction | None | Device Inoperable |
| 2017-04-26 | Malfunction | None | Pumping Stopped, Device Displays Incorrect Message |
| 2017-04-07 | Malfunction | None | Degraded, Device Displays Incorrect Message |
| 2017-03-10 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-12-07 | Malfunction | None | Display or Visual Feedback Problem |
| 2016-10-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-04-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-02-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-08-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-03-31 | Death | None | None |
| 2010-10-19 | Malfunction | None | None |
| 2010-09-27 | Malfunction | None | None |
| 2010-09-14 | Malfunction | None | None |
| 2010-09-13 | Malfunction | None | None |
| 2010-07-14 | Injury | None | None |
| 2010-02-03 | Malfunction | None | None |