FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 1830053
·
Received September 7, 2010
Report
- Report Number
- 9615739-2010-00212
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- August 13, 2010
- Report Date
- August 13, 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 STEERING CASTER WAS DAMAGED AND FOUND TWO CASTER SUPPORTS WERE BROKEN. THE TECH REPLACED THE STEER AND BRAKE CASTER AND THE TWO CASTER SUPPORTS TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE BRAKE IS NOT HOLDING OR STEERING PROPERLY.
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 |