FDA Adverse Event
Malfunction
Summary report: N
4 MOTOR ADVANCE BED
MDR report key: 1984077
·
Received January 14, 2011
Report
- Report Number
- 1824206-2011-00207
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 20, 2010
- Report Date
- December 20, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE LEFT SIDECOM MODULE TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE AUDIBLE SWITCH ON THE BED EXIT CONTROLS WAS WORKING INTERMITTENTLY. THE BED EXIT FUNCTIONED PROPERLY BY PLACING A NURSE CALL, BUT THERE WAS NO TONE LOCALLY ON BED RAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 MOTOR ADVANCE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |