FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2140868
·
Received May 31, 2011
Report
- Report Number
- 1824206-2011-02971
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 5, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT CHECKED THE LINKAGE TO THE EMERGENCY TREND MECHANISM AND FOUND THE VALVE WAS BEING ACTUATED BUT NOT FUNCTIONING. HE REPLACED THE VALVE TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE EMERGENCY TRENDELENBURG WASN'T FUNCTIONING BY USING RED FOOT PEDAL. HE COULD PLACE THE BED IN TREND USING THE SIDERAIL CONTROLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |