FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2142581
·
Received June 21, 2011
Report
- Report Number
- 1824206-2011-03349
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT STATED THE INTELLIDRIVE WILL RUN BACKWARDS AS SOON AS THE ENABLE BUTTON IS PRESSED. THE ACCOUNT HAS ISOLATED THE HANDLES AND REPLACED THE JUNCTION PC BOARD BUT THE ISSUE REMAINS.
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 |