FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2903103
·
Received November 30, 2012
Report
- Report Number
- 1824206-2012-07820
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- 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 A BROKEN SIDE RAIL CENTER ARM ASSEMBLY. THE TECH REPLACED THE SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE SIDE RAIL WOULD NOT LATCH. NO PATIENT IMPACT.
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 |