VENTRICULAR (ASSISST) BYPASS
This device is manufactured by THORATEC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Use of Device Problem | 6 | Device |
| 2024 | No Apparent Adverse Event | 1 | Device |
| 2024 | Mechanical Problem | 9 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Insufficient Information | 3 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 3 | Device |
| 2024 | Electrical Power Problem | 13 | Device |
| 2024 | Disconnection | 3 | Device |
| 2024 | Device Difficult to Setup or Prepare | 3 | Device |
| 2024 | Contamination /Decontamination Problem | 1 | Device |
| 2024 | Complete Loss of Power | 37 | Device |
| 2023 | Use of Device Problem | 6 | Device |
| 2023 | No Apparent Adverse Event | 3 | Device |
| 2023 | Mechanical Problem | 5 | Device |
| 2023 | Material Twisted/Bent | 1 | Device |
| 2023 | Material Discolored | 1 | Device |
| 2023 | Material Deformation | 3 | Device |
| 2023 | Insufficient Information | 7 | Device |
| 2023 | Failure to Power Up | 4 | Device |
| 2023 | Environmental Compatibility Problem | 1 | Device |
| 2023 | Electrical Power Problem | 10 | Device |
| 2023 | Display or Visual Feedback Problem | 2 | Device |
| 2023 | Disconnection | 6 | Device |
| 2023 | Device Difficult to Setup or Prepare | 5 | Device |
| 2023 | Complete Loss of Power | 52 | Device |
| 2023 | Circuit Failure | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | No Apparent Adverse Event | 2 | Device |
| 2022 | Misconnection | 1 | Device |
| 2022 | Mechanical Problem | 4 | Device |
| 2022 | Insufficient Information | 5 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Power Up | 1 | Device |
| 2022 | Failure of Device to Self-Test | 1 | Device |
| 2022 | Electrical Power Problem | 17 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Disconnection | 8 | Device |
| 2022 | Device Difficult to Setup or Prepare | 8 | Device |
| 2022 | Complete Loss of Power | 63 | Device |
| 2021 | No Apparent Adverse Event | 1 | Device |
| 2021 | Disconnection | 1 | Device |
| 2021 | Complete Loss of Power | 1 | Device |
| 2019 | Unintended Electrical Shock | 1 | Device |
| 2019 | Pumping Stopped | 2 | Device |
| 2019 | Power Problem | 120 | Device |
| 2019 | Patient Device Interaction Problem | 1 | Device |
| 2019 | Material Twisted/Bent | 1 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Low Readings | 1 | Device |
| 2019 | Loss of Power | 22 | Device |
| 2019 | Loose or Intermittent Connection | 5 | Device |
| 2019 | Intermittent Loss of Power | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Infusion or Flow Problem | 1 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Electro-Static Discharge | 1 | Device |
| 2019 | Electrical Power Problem | 40 | Device |
| 2019 | Disconnection | 11 | Device |
| 2019 | Device Difficult to Setup or Prepare | 1 | Device |
| 2019 | Connection Problem | 90 | Device |
| 2019 | Complete Loss of Power | 10 | Device |
| 2019 | Communication or Transmission Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Pumping Stopped | 2 | Device |
| 2018 | Power Problem | 162 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Low Readings | 1 | Device |
| 2018 | Loss of Power | 26 | Device |
| 2018 | Loosening of Implant Not Related to Bone-Ingrowth | 1 | Device |
| 2018 | Loose or Intermittent Connection | 12 | Device |
| 2018 | Intermittent Loss of Power | 3 | Device |
| 2018 | Inappropriate or Unexpected Reset | 1 | Device |
| 2018 | High Readings | 1 | Device |
| 2018 | Electro-Static Discharge | 1 | Device |
| 2018 | Electrical Shorting | 1 | Device |
| 2018 | Electrical Power Problem | 37 | Device |
| 2018 | Disconnection | 8 | Device |
| 2018 | Device Stops Intermittently | 1 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Connection Problem | 158 | Device |
| 2018 | Complete Loss of Power | 1 | Device |
| 2018 | Break | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Use of Device Problem | 3 | Device |
| 2017 | Pumping Stopped | 1 | Device |
| 2017 | Power Problem | 13 | Device |
| 2017 | Loss of Power | 5 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2017 | Electrical Power Problem | 5 | Device |
| 2017 | Disconnection | 1 | Device |
| 2017 | Device Stops Intermittently | 1 | Device |
| 2017 | Connection Problem | 21 | Device |