FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3223885
·
Received July 2, 2013
Report
- Report Number
- 1824206-2013-03299
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 5, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE SIDE RAIL CENTER ARM WAS BROKEN RIGHT OFF OF THE BED FRAME AND HANGING FROM THE SIDE RAIL FRAME. MAJOR IMPACT TO BREAK THE PLASTIC HOUSING IS EVIDENT. THE TECHNICIAN REPLACED THE SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE ISSUE WITH BED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE SIDE RAIL IS NOT LATCHING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301513 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |