FDA Adverse Event
Malfunction
Summary report: N
4 MOTOR ADVANCE BED
MDR report key: 2860368
·
Received November 5, 2012
Report
- Report Number
- 1824206-2012-07129
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Date of Event
- June 30, 2008
- Report Date
- June 30, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE SIDERAIL WAS DAMAGED AT BOTH THE PIVOT POINTS AND COMPLETELY SEPARATED FROM THE UPRIGHTS AND SIDE GUARD. HE REPLACED SIDERAIL ASSEMBLY TO REPAIR THE BED.
Description of Event or Problem · 1
THE COMPLAINANT STATED THAT THE LEFT SIDERAIL WAS BROKEN DUE TO THE PATIENT USING THE SIDERAIL TO HELP THEMSELVES IN AND OUT OF BED INTO A WHEELCHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 MOTOR ADVANCE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |