FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2000041
·
Received February 3, 2011
Report
- Report Number
- 1824206-2011-00633
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 21, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE HEAD UP NOT WORKING AND WOULD NOT WORK MANUALLY DUE TO HEAD UP VALVE BEING STUCK. REPLACED HEAD UP VALVE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
COMPLAINT RECEIVED ALLEGED THAT THE HEAD UP FUNCTION WAS NOT WORKING ON THIS BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900D003362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |