LVAD SYSTEM CONTROLLER
This device is manufactured by THORATEC CORP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2017 | Electrical /Electronic Property Problem | 1 | Device |
| 2017 | Device Alarm System | 1 | Device |
| 2017 | Computer Operating System Problem | 1 | Device |
| 2014 | Insufficient Information | 1 | Patient |
| 2014 | Failure of Implant | 1 | Patient |
| 2014 | Vibration | 2 | Device |
| 2014 | Use of Device Problem | 5 | Device |
| 2014 | Self-Activation or Keying | 1 | Device |
| 2014 | Pumping Stopped | 7 | Device |
| 2014 | Premature Discharge of Battery | 1 | Device |
| 2014 | Power Problem | 17 | Device |
| 2014 | Peeled/Delaminated | 1 | Device |
| 2014 | Overheating of Device | 4 | Device |
| 2014 | Out-Of-Box Failure | 1 | Device |
| 2014 | Other (for use when an appropriate device code cannot be identified) | 2 | Device |
| 2014 | Noise, Audible | 1 | Device |
| 2014 | No Display/Image | 2 | Device |
| 2014 | No Audible Alarm | 7 | Device |
| 2014 | Low Readings | 1 | Device |
| 2014 | Loss of Power | 2 | Device |
| 2014 | Infusion or Flow Problem | 14 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2014 | High Readings | 3 | Device |
| 2014 | Failure to Power Up | 1 | Device |
| 2014 | Electro-Static Discharge | 1 | Device |
| 2014 | Disconnection | 2 | Device |
| 2014 | Difficult to Open or Close | 1 | Device |
| 2014 | Device Stops Intermittently | 38 | Device |
| 2014 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Device Alarm System | 14 | Device |
| 2014 | Detachment Of Device Component | 1 | Device |
| 2014 | Decreased Pump Speed | 10 | Device |
| 2014 | Data Problem | 2 | Device |
| 2014 | Connection Problem | 7 | Device |
| 2014 | Communication or Transmission Problem | 9 | Device |
| 2014 | Circuit Failure | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Battery Problem | 1 | Device |
| 2014 | Alarm Not Visible | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Pumping Stopped | 7 | Device |
| 2013 | Power Problem | 1 | Device |
| 2013 | Overheating of Device | 1 | Device |
| 2013 | Output Problem | 1 | Device |
| 2013 | Other (for use when an appropriate device code cannot be identified) | 14 | Device |
| 2013 | No Audible Alarm | 1 | Device |
| 2013 | Insufficient Information | 1 | Device |
| 2013 | Infusion or Flow Problem | 2 | Device |
| 2013 | Device Stops Intermittently | 3 | Device |
| 2013 | Device Operates Differently Than Expected | 1 | Device |
| 2013 | Device Damaged by Another Device | 2 | Device |
| 2013 | Device Alarm System | 1 | Device |
| 2013 | Decreased Pump Speed | 2 | Device |
| 2013 | Connection Problem | 1 | Device |
| 2013 | Break | 1 | Device |