FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2081610
·
Received April 13, 2011
Report
- Report Number
- 1824206-2011-02142
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT INSTALLED A NEW COILED CABLE AND NOW THE LEDS ON THE LOGIC BOARD ARE ALL OFF (INDICATING A BOOT-LOADER ERROR). THE ACCOUNT REPLACED THE LOGIC BOARD TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED THE BED IS FLASHING A SYSTEM HEARTBEAT FAILURE DUE TO AN EXPOSED BARE WIRE ON THE COILED CABLE.
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 | UNK |