VENTRICULAR (ASSIST) BYPASS
This device is manufactured by HEARTWARE, MEDTRONIC / HEARTWARE.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2019 | Use of Device Problem | 2 | Device |
| 2019 | Pumping Stopped | 3 | Device |
| 2019 | Power Problem | 27 | Device |
| 2019 | Poor Quality Image | 2 | Device |
| 2019 | Overheating of Device | 2 | Device |
| 2019 | No Display/Image | 1 | Device |
| 2019 | No Audible Alarm | 1 | Device |
| 2019 | Material Twisted/Bent | 13 | Device |
| 2019 | Low Audible Alarm | 1 | Device |
| 2019 | Loose or Intermittent Connection | 8 | Device |
| 2019 | Incomplete or Inadequate Connection | 4 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Electrical /Electronic Property Problem | 10 | Device |
| 2019 | Display or Visual Feedback Problem | 1 | Device |
| 2019 | Disconnection | 2 | Device |
| 2019 | Device Fell | 1 | Device |
| 2019 | Device Alarm System | 8 | Device |
| 2019 | Date/Time-Related Software Problem | 1 | Device |
| 2019 | Data Problem | 1 | Device |
| 2019 | Connection Problem | 13 | Device |
| 2019 | Complete Loss of Power | 1 | Device |
| 2019 | Battery Problem | 1 | Device |
| 2019 | Audible Prompt/Feedback Problem | 1 | Device |
| 2018 | Use of Device Problem | 13 | Device |
| 2018 | Pumping Stopped | 4 | Device |
| 2018 | Pumping Problem | 1 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Power Problem | 83 | Device |
| 2018 | Poor Quality Image | 1 | Device |
| 2018 | Nonstandard Device | 1 | Device |
| 2018 | Noise, Audible | 2 | Device |
| 2018 | No Display/Image | 2 | Device |
| 2018 | No Audible Alarm | 3 | Device |
| 2018 | Material Twisted/Bent | 4 | Device |
| 2018 | Material Integrity Problem | 7 | Device |
| 2018 | Material Deformation | 9 | Device |
| 2018 | Loose or Intermittent Connection | 7 | Device |
| 2018 | Incomplete or Inadequate Connection | 1 | Device |
| 2018 | Inadequate User Interface | 1 | Device |
| 2018 | Electrical /Electronic Property Problem | 4 | Device |
| 2018 | Display or Visual Feedback Problem | 2 | Device |
| 2018 | Disconnection | 16 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Operational Issue | 1 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Inoperable | 10 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Device Displays Incorrect Message | 21 | Device |
| 2018 | Device Alarm System | 4 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Date/Time-Related Software Problem | 6 | Device |
| 2018 | Data Problem | 7 | Device |
| 2018 | Connection Problem | 29 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Bent | 1 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Use of Device Problem | 15 | Device |
| 2017 | Pumping Stopped | 13 | Device |
| 2017 | Pumping Problem | 1 | Device |
| 2017 | Protective Measures Problem | 8 | Device |
| 2017 | Power Problem | 380 | Device |
| 2017 | Overheating of Device | 3 | Device |
| 2017 | Noise, Audible | 3 | Device |
| 2017 | No Display/Image | 3 | Device |
| 2017 | No Audible Alarm | 1 | Device |
| 2017 | Missing Value Reason | 1 | Device |
| 2017 | Material Integrity Problem | 2 | Device |
| 2017 | Low Audible Alarm | 1 | Device |
| 2017 | Loose or Intermittent Connection | 37 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Incomplete or Inadequate Connection | 4 | Device |
| 2017 | Failure to Pump | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 12 | Device |
| 2017 | Display or Visual Feedback Problem | 2 | Device |
| 2017 | Disconnection | 20 | Device |
| 2017 | Device Inoperable | 5 | Device |
| 2017 | Device Emits Odor | 1 | Device |
| 2017 | Device Displays Incorrect Message | 14 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Device Alarm System | 6 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Date/Time-Related Software Problem | 5 | Device |
| 2017 | Data Problem | 5 | Device |
| 2017 | Contamination /Decontamination Problem | 1 | Device |
| 2017 | Connection Problem | 30 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Bent | 1 | Device |
| 2017 | Battery Problem | 2 | Device |
| 2017 | Alarm Not Visible | 1 | Device |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Pumping Stopped | 1 | Device |
| 2016 | Protective Measures Problem | 3 | Device |
| 2016 | Power Problem | 6 | Device |
| 2016 | No Fail-Safe Mechanism | 1 | Device |
| 2016 | No Display/Image | 2 | Device |
| 2016 | No Audible Alarm | 1 | Device |
| 2016 | Material Integrity Problem | 1 | Device |
| 2016 | Loose or Intermittent Connection | 4 | Device |
| 2016 | Leak/Splash | 1 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2016 | Display or Visual Feedback Problem | 2 | Device |
| 2016 | Disconnection | 2 | Device |
| 2016 | Device Issue | 1 | Device |
| 2016 | Device Displays Incorrect Message | 9 | Device |
| 2016 | Device Alarm System | 1 | Device |
| 2016 | Connection Problem | 4 | Device |
| 2016 | Appropriate Term/Code Not Available | 4 | Device |
| 2015 | Pumping Stopped | 1 | Device |
| 2015 | Protective Measures Problem | 1 | Device |
| 2015 | Material Integrity Problem | 1 | Device |
| 2015 | Device Displays Incorrect Message | 46 | Device |
| 2015 | Date/Time-Related Software Problem | 17 | Device |
| 2015 | Connection Problem | 8 | Device |
| 2015 | Bent | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Power Problem | 2 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Device Alarm System | 1 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Defective Device | 1 | Device |
| 2013 | Connection Problem | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 2 | Device |
| 2011 | Connection Problem | 1 | Device |