FDA Adverse Event
Malfunction
Summary report: N
VERSACARE
MDR report key: 1113004
·
Received August 15, 2008
Report
- Report Number
- 1824206-2008-00908
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- August 23, 2006
- Report Date
- August 23, 2006
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Removal / Correction Number
- Z-0240-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLAINT REVIEW IT WAS DETERMINED THAT IS A REPORTABLE EVENT FOR SIDERAIL NOT LATCHING. REPLACEMENT INLINE SPRING KIT INSTALLED WHICH RESOLVED THE PROBLEM.
Description of Event or Problem · 1
RIGHT HEAD SIDERAIL WOULD NOT LATCH IN THE UP POSITION. THERE WERE NO INJURIES IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | P3200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |