FDA Adverse Event
Injury
Summary report: N
SYNCARDIA CARDIOWEST
MDR report key: 2933781
·
Received January 29, 2013
Report
- Report Number
- 2933781
- Event Type
- Injury
- Date Received
- January 29, 2013
- Date of Event
- July 31, 2012
- Report Date
- January 29, 2013
- Manufacturer
- SYNCARDIA CARDIOWEST
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TAH MONITOR WAS SHORT CIRCUITING AND SHUTTING OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39631 | SYNCARDIA CARDIOWEST | TOTAL ARTIFICIAL HEART | DSQ | SYNCARDIA CARDIOWEST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |