FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 1934132
·
Received December 3, 2010
Report
- Report Number
- 1824206-2010-11376
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 9, 2010
- Report Date
- November 9, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE COILED COMM CABLE TO REPAIR THE BED.
Description of Event or Problem · 1
THE (B)(6) ALLEGED THAT SOMEONE TOUCHED THE BED AND WAS SHOCKED. HE STATED HE WAS NOT INJURED. THE ACCOUNT ALLEGED THE ISSUE WAS WITH THE COILED COMM CABLE. THE CABLE WAS DAMAGED AND ALLOWED THE METAL WIRES TO BECOME EXPOSED AND IT APPEARS THE CASTER WAS RUBBING ON THE CORD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |