FDA Adverse Event
Injury
Summary report: N
VENTRASSIST
MDR report key: 1293973
·
Received January 21, 2009
Report
- Report Number
- MW5009705
- Event Type
- Injury
- Date Received
- January 21, 2009
- Date of Event
- January 20, 2009
- Report Date
- January 21, 2009
- Manufacturer
- VENTRACOR INC
- Product Code
- DSQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
VENTRASSIST VAD PLACED. ELECTRICAL PUMP FAILURE YESTERDAY. PUMP REPLACED TODAY. DEVICE TAKEN BY VAD COORD. FAILED MEDICAL DEVICE COMPLETED AND FAXED TO RISK MGMT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTRASSIST | VENTRASSIST VAD | DSQ | VENTRACOR INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Disability |