VENTRICULAR (ASSIST) BYPASS
This device is manufactured by CARDINAL HEALTH, HEARTWARE, HEARTWARE-MEDTRONIC.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Dementia | 1 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Use of Device Problem | 6 | Device |
| 2024 | Pumping Stopped | 5 | Device |
| 2024 | Pumping Problem | 5 | Device |
| 2024 | Power Problem | 26 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | No Audible Alarm | 1 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Material Twisted/Bent | 4 | Device |
| 2024 | Material Integrity Problem | 1 | Device |
| 2024 | Low Audible Alarm | 2 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Failure to Pump | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 7 | Device |
| 2024 | Display or Visual Feedback Problem | 3 | Device |
| 2024 | Disconnection | 5 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2024 | Date/Time-Related Software Problem | 1 | Device |
| 2024 | Data Problem | 3 | Device |
| 2024 | Contamination /Decontamination Problem | 2 | Device |
| 2024 | Connection Problem | 7 | Device |
| 2024 | Battery Problem | 59 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Use of Device Problem | 9 | Device |
| 2023 | Pumping Problem | 3 | Device |
| 2023 | Power Problem | 32 | Device |
| 2023 | Overheating of Device | 1 | Device |
| 2023 | No Audible Alarm | 1 | Device |
| 2023 | Moisture Damage | 1 | Device |
| 2023 | Material Twisted/Bent | 6 | Device |
| 2023 | Material Integrity Problem | 3 | Device |
| 2023 | Low Audible Alarm | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 10 | Device |
| 2023 | Display or Visual Feedback Problem | 4 | Device |
| 2023 | Disconnection | 4 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2023 | Device Alarm System | 2 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Connection Problem | 13 | Device |
| 2023 | Battery Problem | 58 | Device |
| 2022 | Use of Device Problem | 3 | Device |
| 2022 | Pumping Stopped | 1 | Device |
| 2022 | Pumping Problem | 2 | Device |
| 2022 | Power Problem | 32 | Device |
| 2022 | Material Twisted/Bent | 8 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Loss of Power | 1 | Device |
| 2022 | Incomplete or Inadequate Connection | 1 | Device |
| 2022 | Failure to Pump | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 8 | Device |
| 2022 | Disconnection | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Device Alarm System | 2 | Device |
| 2022 | Date/Time-Related Software Problem | 2 | Device |
| 2022 | Connection Problem | 5 | Device |
| 2022 | Battery Problem | 48 | Device |
| 2021 | Power Problem | 1 | Device |
| 2021 | Material Twisted/Bent | 1 | Device |
| 2021 | Material Integrity Problem | 2 | Device |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 1 | Device |
| 2021 | Connection Problem | 6 | Device |
| 2021 | Bent | 1 | Device |
| 2020 | Power Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |