FDA Adverse Event
Malfunction
Summary report: N
634 AFFINITY BED
MDR report key: 1945951
·
Received December 28, 2010
Report
- Report Number
- 1824206-2010-11916
- Event Type
- Malfunction
- Date Received
- December 28, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE BRAKE CASTER WAS OUT OF ADJUSTMENT. HE ADJUSTED THE CASTER AND THE BRAKES FUNCTIONED PROPERLY.
Description of Event or Problem · 1
TECHNICIAN FOUND THAT WHEN THE BRAKES WERE ENGAGED THE FOOT CASTER DID NOT HOLD. NO ALLEGED INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 634 AFFINITY BED | BIRTHING BED | HDD | HILL-ROM INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |