FDA Adverse Event
Malfunction
Summary report: N
REMANUFACTURED BED
MDR report key: 1954011
·
Received December 16, 2010
Report
- Report Number
- 1824206-2010-11680
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND GREASE MIGRATED FROM THE DRIVE SCREW TO THE HI/LOW DRIVE BRAKE DRUM. HE CLEANED THE BRAKE DRUM TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES, THE HI/LOW FUNCTION IS DRIFTING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMANUFACTURED BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 8400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |