FDA Adverse Event
Malfunction
Summary report: N
AMSCO 3085 SP SURGICAL TABLE
MDR report key: 1010536
·
Received March 5, 2008
Report
- Report Number
- 1010536
- Event Type
- Malfunction
- Date Received
- March 5, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 5, 2008
- Manufacturer
- STERIS CORPORATION
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE POSITIONING THE OR BED IT LOST POWER. NO CONTROLS ON THE REMOTE OR ON THE BED WOULD ALLOW THE BED TO BE POSITIONED IN LITHOTOMY/FOOT DOWN POSITION. BED WOULD NOT UNLOCK. PATIENT TRANSFERRED TO ANOTHER ROOM, REPOSITIONED AND SURGERY PERFORMED. BED TAKEN TO ENGINEERING FOR REPAIR. REPAIR HAS NOT BEEN COMPLETED AS OF THIS DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMSCO 3085 SP SURGICAL TABLE | TABLE, SURGICAL | FQO | STERIS CORPORATION | 3085 SP | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |