FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2010015
·
Received March 2, 2011
Report
- Report Number
- 1824206-2011-01217
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THE BED IN STORAGE AREA. CHECKED THE BED, AND CHECKED THE FUNCTIONS. THE HEAD UP VALVE WAS STUCK IN THE OPEN POSITION. REPLACED THE HEAD UP VALVE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT THE HEAD UP FUNCTION WAS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900F006097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |