LVAD SYSTEM CONTROLLER
This device is manufactured by ABBOTT / THORATEC CORP, ABBOTT / THORATEC CORPORATION, THORATEC CORP, THORATEC CORPORATION, THORATEC CORPORATION / ABBOTT LABORATORIES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Unintended Electrical Shock | 1 | Device |
| 2024 | Pumping Stopped | 3 | Device |
| 2024 | Product Quality Problem | 2 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | Noise, Audible | 1 | Device |
| 2024 | No Audible Alarm | 4 | Device |
| 2024 | No Apparent Adverse Event | 5 | Device |
| 2024 | Melted | 1 | Device |
| 2024 | Mechanical Problem | 17 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Deformation | 16 | Device |
| 2024 | Low Audible Alarm | 4 | Device |
| 2024 | Insufficient Information | 28 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 15 | Device |
| 2024 | Fire | 1 | Device |
| 2024 | Failure to Charge | 13 | Device |
| 2024 | Electro-Static Discharge | 1 | Device |
| 2024 | Electrical Power Problem | 43 | Device |
| 2024 | Electrical /Electronic Property Problem | 12 | Device |
| 2024 | Display or Visual Feedback Problem | 11 | Device |
| 2024 | Display Difficult to Read | 4 | Device |
| 2024 | Disconnection | 22 | Device |
| 2024 | Device Difficult to Setup or Prepare | 4 | Device |
| 2024 | Device Alarm System | 2 | Device |
| 2024 | Complete Loss of Power | 17 | Device |
| 2024 | Communication or Transmission Problem | 11 | Device |
| 2024 | Alarm Not Visible | 1 | Device |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Loss of consciousness | 3 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Electric Shock | 3 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Burn(s) | 2 | Patient |
| 2023 | Unintended Electrical Shock | 4 | Device |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Separation Failure | 1 | Device |
| 2023 | Pumping Stopped | 3 | Device |
| 2023 | Overheating of Device | 7 | Device |
| 2023 | Nonstandard Device | 1 | Device |
| 2023 | No Display/Image | 3 | Device |
| 2023 | No Audible Alarm | 2 | Device |
| 2023 | No Apparent Adverse Event | 8 | Device |
| 2023 | Mechanical Problem | 46 | Device |
| 2023 | Material Twisted/Bent | 2 | Device |
| 2023 | Material Deformation | 18 | Device |
| 2023 | Insufficient Information | 35 | Device |
| 2023 | Infusion or Flow Problem | 6 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 19 | Device |
| 2023 | Failure to Power Up | 2 | Device |
| 2023 | Failure to Interrogate | 2 | Device |
| 2023 | Failure to Charge | 3 | Device |
| 2023 | Failure of Device to Self-Test | 2 | Device |
| 2023 | Electrical Power Problem | 63 | Device |
| 2023 | Electrical /Electronic Property Problem | 14 | Device |
| 2023 | Display or Visual Feedback Problem | 8 | Device |
| 2023 | Display Difficult to Read | 8 | Device |
| 2023 | Disconnection | 41 | Device |
| 2023 | Device Difficult to Setup or Prepare | 12 | Device |
| 2023 | Device Alarm System | 2 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Dent in Material | 2 | Device |
| 2023 | Data Problem | 2 | Device |
| 2023 | Corroded | 5 | Device |
| 2023 | Complete Loss of Power | 21 | Device |
| 2023 | Communication or Transmission Problem | 12 | Device |
| 2023 | Alarm Not Visible | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unintended Electrical Shock | 3 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Pumping Stopped | 1 | Device |
| 2022 | Overheating of Device | 1 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Noise, Audible | 2 | Device |
| 2022 | No Display/Image | 2 | Device |
| 2022 | No Audible Alarm | 1 | Device |
| 2022 | No Apparent Adverse Event | 8 | Device |
| 2022 | Mechanical Problem | 34 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Deformation | 15 | Device |
| 2022 | Low Audible Alarm | 5 | Device |
| 2022 | Insufficient Information | 28 | Device |
| 2022 | Infusion or Flow Problem | 4 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 9 | Device |
| 2022 | Failure to Charge | 4 | Device |
| 2022 | Failure of Device to Self-Test | 1 | Device |
| 2022 | Electrical Power Problem | 36 | Device |
| 2022 | Electrical /Electronic Property Problem | 15 | Device |
| 2022 | Display or Visual Feedback Problem | 12 | Device |
| 2022 | Display Difficult to Read | 1 | Device |
| 2022 | Disconnection | 30 | Device |
| 2022 | Device Difficult to Setup or Prepare | 6 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Corroded | 1 | Device |
| 2022 | Complete Loss of Power | 16 | Device |
| 2022 | Communication or Transmission Problem | 10 | Device |
| 2022 | Alarm Not Visible | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | No Apparent Adverse Event | 2 | Device |
| 2021 | Mechanical Problem | 1 | Device |
| 2021 | Material Deformation | 2 | Device |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 1 | Device |
| 2021 | Disconnection | 1 | Device |
| 2020 | Noise, Audible | 1 | Device |
| 2020 | Mechanical Problem | 1 | Device |
| 2020 | Disconnection | 1 | Device |
| 2020 | Complete Loss of Power | 1 | Device |
| 2019 | Unintended Electrical Shock | 3 | Device |
| 2019 | Pumping Stopped | 7 | Device |
| 2019 | Power Problem | 2 | Device |
| 2019 | Overheating of Device | 1 | Device |
| 2019 | No Display/Image | 1 | Device |
| 2019 | Naturally Worn | 1 | Device |
| 2019 | Moisture or Humidity Problem | 1 | Device |
| 2019 | Moisture Damage | 2 | Device |
| 2019 | Misconnection | 2 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Split, Cut or Torn | 4 | Device |
| 2019 | Loss of Power | 1 | Device |
| 2019 | Loss of Data | 1 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Insufficient Flow or Under Infusion | 2 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | False Negative Result | 1 | Device |
| 2019 | Failure to Pump | 1 | Device |
| 2019 | Disconnection | 2 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Device Emits Odor | 1 | Device |
| 2019 | Device Difficult to Setup or Prepare | 1 | Device |
| 2019 | Device Damaged by Another Device | 1 | Device |
| 2019 | Connection Problem | 5 | Device |
| 2019 | Complete Loss of Power | 1 | Device |
| 2019 | Communication or Transmission Problem | 7 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Thermal Decomposition of Device | 1 | Device |
| 2018 | Pumping Stopped | 7 | Device |
| 2018 | Power Problem | 4 | Device |
| 2018 | Overheating of Device | 2 | Device |
| 2018 | Operating System Becomes Nonfunctional | 1 | Device |
| 2018 | Misconnection | 5 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Infusion or Flow Problem | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Electrical Shorting | 1 | Device |
| 2018 | Disconnection | 1 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Stops Intermittently | 2 | Device |
| 2018 | Device Alarm System | 2 | Device |
| 2018 | Data Problem | 2 | Device |
| 2018 | Connection Problem | 10 | Device |
| 2018 | Communication or Transmission Problem | 6 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Thermal Decomposition of Device | 2 | Device |
| 2017 | No Audible Alarm | 1 | Device |
| 2017 | Kinked | 1 | Device |
| 2017 | Infusion or Flow Problem | 1 | Device |
| 2017 | High Readings | 2 | Device |
| 2017 | Expiration Date Error | 3 | Device |
| 2017 | Electrical Shorting | 1 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Connection Problem | 4 | Device |
| 2017 | Communication or Transmission Problem | 1 | Device |
| 2017 | Circuit Failure | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |