FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2043369
·
Received March 15, 2011
Report
- Report Number
- 1824206-2011-01570
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN INSPECTED THE BED AND COULD NOT RECREATE THE ALLEGED MALFUNCTION. THE BED EXIT WAS STAYING ARMED UNTIL IT ALARMED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BED EXIT WAS ARMED AND WOULD SHUT ITSELF OFF.
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 |