FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 3032099
·
Received March 6, 2013
Report
- Report Number
- 9615739-2013-00061
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 7, 2013
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE SCALE BOARD TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THERE IS NO AUDIBLE ALARM FOR THE BED EXIT ON THE BED. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96461 | CAREASSIST BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM PLUVIGNER | 1170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |