FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1946307
·
Received December 14, 2010
Report
- Report Number
- 1824206-2010-11560
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE BED WOULD NOT GO INTO EMERGENCY TREND WHEN RAISED IN THE FULL UP POSITION. REPLACED TREND VALVE KIT TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
FACILITY STATED WHEN THE HI/LOW IS ALL THE WAY UP, THAT THE EMERGENCY TREND (RED HANDLE) DOES NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900N006971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |