FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3240856
·
Received July 16, 2013
Report
- Report Number
- 1824206-2013-03524
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 19, 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 ACCOUNT FOUND THE SIDE RAIL CENTER ARM WAS DAMAGED. THE ACCOUNT REPLACED THE SIDE RAIL CENTER ARM ASSEMBLY TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE SIDE RAIL DID NOT LATCH. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330433 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |