FDA Adverse Event
Malfunction
Summary report: N
CAREASSIST BED
MDR report key: 2112473
·
Received April 28, 2011
Report
- Report Number
- 9615739-2011-00107
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- HILL-ROM PLUVIGNER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE HEAD DRIVE WAS DAMAGED BY A STUCK HEAD UP BUTTON IN THE LEFT SIDERAIL. HE REPLACED THE HEAD DRIVE MOTOR AND THE CAREGIVER CONTROLS ON THE LEFT SIDERAIL TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED THE HEAD SECTION IS FULLY RAISED AND WILL NOT LOWER ELECTRICALLY OR BY ACTIVATING THE CPR.
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 |