FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2012069
·
Received February 14, 2011
Report
- Report Number
- 1824206-2011-00846
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 21, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE CENTER ARM ASSEMBLY WAS DAMAGED, POSSIBLY FROM ABUSE. HE REPLACED THE SIDERAIL CENTER ARM ASSEMBLY TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE TECH WAS UNABLE TO LOCK THE SIDERAIL IN PLACE.
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 |