FDA Adverse Event
Malfunction
Summary report: N
OBGYN TRANSTAR TRANSTAR FRAME OB/G
MDR report key: 1730744
·
Received December 22, 2009
Report
- Report Number
- 1824206-2009-07830
- Event Type
- Malfunction
- Date Received
- December 22, 2009
- Date of Event
- November 19, 2007
- Report Date
- November 19, 2007
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECH REPLACED THE CONNECTION ROD AND THE LEFT FOOT CASTER 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
ACCOUNT ALLEGED THAT THE BRAKES ON FOOT SECTION WERE 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 | P8050D3885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |