FDA Adverse Event
Malfunction
Summary report: N
HEARTMATELL
MDR report key: 2401281
·
Received January 3, 2012
Report
- Report Number
- 2401281
- Event Type
- Malfunction
- Date Received
- January 3, 2012
- Date of Event
- September 14, 2011
- Report Date
- December 23, 2011
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE LVAD CONTROLLER FAILED TO WORK AFTER THE LVAD WAS CONNECTED TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATELL | EXTERNAL LVAD CONTOLLER | DSQ | THORATEC CORP. | HEARTMATELL | REF 103694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |