FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2253838
·
Received August 11, 2011
Report
- Report Number
- 1824206-2011-04265
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 1, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT THE CASTER WAS OUT OF ADJUSTMENT. HE ADJUSTED THE CASTERS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES WHEN THE BRAKES WERE ENGAGED THE RIGHT HEAD CASTER DID NOT HOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |