FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2910553
·
Received December 3, 2012
Report
- Report Number
- 1824206-2012-07857
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION RECEIVED THE TREND VALVE MAY HAVE BEEN STUCK. THE TREND HANDLE WAS MOVED AND THE BED STARTED TO OPERATE PROPERLY. MOVING THE TREND HANDLE MAY HAVE RELEASED THE TREND VALVE. BED IS BACK IN SERVICE WITH NO ISSUES.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THE BED WOULD DRIFT INTO THE TRENDELENBURG POSITION WHEN THE HEAD UP FUNCTION WAS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |