FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2130297
·
Received May 9, 2011
Report
- Report Number
- 1824206-2011-02601
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 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 TESTED THE BED WITH 200 LBS ON THE HEAD SECTION FOR TWO DAYS AND THE HEAD SECTION DIDN'T DRIFT DOWN AT ALL. HE THEN TESTED ALL BED FUNCTIONS AS WELL AS THE CPR AND FOUND NO PROBLEMS. HE ALSO PERFORMED A FUNCTIONS CHECK ON ALL SYSTEMS AND FOUND NO PROBLEMS.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BEDS HEAD ACTUATOR HAS BEEN LOWERING ON ITS OWN.
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 |