FDA Adverse Event
Malfunction
Summary report: N
OBGYN TRANSTAR
MDR report key: 2212139
·
Received July 8, 2011
Report
- Report Number
- 1824206-2011-03628
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE SIDERAIL WOULD NOT LATCH BECAUSE THE NUT WAS MISSING FROM THE BOLT. THE END TUBE WAS BENT AND MISSING THE SCREWS. REPLACED WITH NEW TUBE AND SCREW SET TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT THE SIDERAIL WAS NOT LATCHING. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBGYN TRANSTAR | WHEELED STRETCHER | FPO | HILL-ROM, INC. | P8050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |