FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR FRAME OB/G
MDR report key: 2135121
·
Received June 15, 2011
Report
- Report Number
- 1824206-2011-03269
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND THE PT LEFT SIDERAIL WAS NOT LATCHING DUE TO MISSING BOLT TO BASE. REPLACED THE BOLT TO THE LATCH TUBE BASE TO RESOLVE THIS ISSUE. PROBLEM WAS RESULT OF MISUSE.
Description of Event or Problem · 1
COMPLAINT RECEIVED OF PT LEFT SIDERAIL BROKEN. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR FRAME OB/G | WHEELED STRETCHER | FPO | HILL-ROM INC. | P8050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |