FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 1960141
·
Received December 17, 2010
Report
- Report Number
- 1824206-2010-11698
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- November 29, 2010
- Report Date
- November 29, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT ORDERED A REPLACEMENT LEFT HEAD COILED CABLE. NO FURTHER INFO IS AVAILABLE ON THE REPAIR AT THIS TIME.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THE LEFT HEAD COILED CABLE WAS CUT EXPOSING BARE METAL WIRES. ACCOUNT STATED THAT THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |