FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 3252851
·
Received July 15, 2013
Report
- Report Number
- 9615739-2013-00199
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 18, 2013
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT WHEN THE BED IS PLACED IN TRENDELENBERG, THE BED RUNS BACK UP TO LEVEL POSITION. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326127 | CAREASSIST BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |