FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3223821
·
Received July 2, 2013
Report
- Report Number
- 1824206-2013-03311
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN TESTED THE BED EXIT AND FOUND TO FUNCTION AS DESIGNED, USER ERROR.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BED EXIT ALARM IS NOT SETTING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300493 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |