FDA Adverse Event
Malfunction
Summary report: N
OBGYN TRANSTAR TRANSTAR FRAME OB/G
MDR report key: 1740352
·
Received December 23, 2009
Report
- Report Number
- 1824206-2009-07885
- Event Type
- Malfunction
- Date Received
- December 23, 2009
- Date of Event
- December 21, 2007
- Report Date
- December 21, 2007
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN REPLACED BOTH BRAKE LINKAGES ON THE STRETCHER TO RESOLVE THE ISSUE. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE BRAKE WAS NOT HOLDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBGYN TRANSTAR TRANSTAR FRAME OB/G | WHEELED STRETCHER | FPO | HILL-ROM RITTER | P8050D3886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |