FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 2031506
·
Received March 21, 2011
Report
- Report Number
- 9615739-2011-00072
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE COMPLETE PENDANT TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BUTTONS ON THE FACING OF THE CAREASSIST PENDANTS ARE WEARING THROUGH WHICH HAS ALLOWED FLUID INGRESS INTO THE PENDANT AS A RESULT.
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 | UNK |