FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2002098
·
Received February 4, 2011
Report
- Report Number
- 1824206-2011-00641
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 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
TECH FOUND THE BED IN "DOWN" STORAGE AREA. HEAD UP FUNCTION NOT WORKING MANUALLY OR UNDER POWER. BATTERY LED IS ON. PROBLEM DETERMINED TO BE FAULTY VALVE GUIDE TUBE. REPLACED HEAD UP VALVE GUIDE TUBE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT HEAD UP FUNCTION WAS NOT WORKING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900D004428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |