FDA Adverse Event
Malfunction
Summary report: N
OBGYN TRANSTAR TRANSTAR FRAME OB/G
MDR report key: 1632719
·
Received March 8, 2010
Report
- Report Number
- 1824206-2010-03588
- Event Type
- Malfunction
- Date Received
- March 8, 2010
- Date of Event
- April 21, 2008
- Report Date
- April 21, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECH REPLACED THE MISSING NUT AND BOLT FASTENING TRENDELENBURG CONNECTING ROD TO PEDALS AND ADJUSTED THE TRENDELENBURG OFFSET PLUNGER 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
TECH ALLEGED THAT THE STRETCHER WILL NOT GO INTO TRENDELENBURG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OBGYN TRANSTAR TRANSTAR FRAME OB/G | WHEELED STRETCHER | FPO | HILL-ROM RITTER | P8050D000908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |