FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 2191765
·
Received July 28, 2011
Report
- Report Number
- 9615739-2011-00191
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 2011
- 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 TECHNICIAN REPLACED ONE STEER AND TWO BRAKE CASTERS AND THE CASTER SUPPORTS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE IS NOT HOLDING. THE CASTERS ARE LOCKING BUT CONTINUE TO SWIVEL SIDE TO SIDE WHEN IN BRAKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREASSIST BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |