FDA Adverse Event
Other
Summary report: N
SHAMPAINE
MDR report key: 802513
·
Received December 1, 2004
Report
- Report Number
- 3019090-2004-00002
- Event Type
- Other
- Date Received
- December 1, 2004
- Report Date
- November 4, 2004
- Manufacturer
- GETINGE USA, INC, F.K.A MDT DIAGNOSTIC E.
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PILOT OPERATED CHECK VALVE WAS REPLACED AND PROPER OPERATION OF THE TABLE WAS VERIFIED. REPRESENTATIVE EXAMINED THE VALVE AND THE CONCLUSION IS THAT THE DRIFTING WAS MOST LIKELY CAUSED BY A PIECE OF CONTAMINANT BECOMING LODGED BETWEEN THE SEAL AND THE PISTON AT THE INSTANT THAT THE PISTON CLOSED ALLOWING FLUID TO FLOW.
Description of Event or Problem · 1
DURING SURGERY, THE TABLE WAS PUT INTO SLIGHT TRENDELENBURG POSITION BY OR STAFF. AFTER MOTOR WAS OFF THE TABLE DRIFTED INTO FULL TRENDELENBURG POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHAMPAINE | SURGICAL TABLE | FQO | GETINGE USA, INC, F.K.A MDT DIAGNOSTIC E. | 5100B | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |