FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 1800664
·
Received August 4, 2010
Report
- Report Number
- 9615739-2010-00189
- Event Type
- Malfunction
- Date Received
- August 4, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 12, 2010
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE RIGHT FOOT CASTER BROKEN AT THE STEM AND THE BRAKE ROD LOCATED ON THE HEAD CASTERS BACKED OUT FROM THE BRAKE BAR AND THE PLASTIC BUSHING WAS BROKEN. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKES WERE NOT HOLDING ON THIS BED AND A PT FELL, HOWEVER, NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREASSIST BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |