FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 2191766
·
Received July 28, 2011
Report
- Report Number
- 9615739-2011-00193
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 15, 2011
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE CASTERS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE IS NOT STAYING ENGAGED. THE BRAKE WILL SET AND HOLD BUT WHEN PRESSURE IS APPLIED TO THE BED, THE BRAKE PEDAL POPS OUT OF THE BRAKE POSITION.
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 |