FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2233223
·
Received July 22, 2011
Report
- Report Number
- 1824206-2011-03879
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 5, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND HEAD UP FUNCTION WAS NOT WORKING MANUALLY OR UNDER POWER. BATTERY LED WAS ON. DETERMINED PROBLEM TO BE FAULTY VALVE GUIDE TUBE. REPLACED THE HEAD UP VALVE GUIDE TUBE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
BED FOUND IN "DOWN" STORAGE. NO PT IMPACT REPORTED. HEAD UP FUNCTION NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 721 | P1900G006311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |