FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2022400
·
Received February 16, 2011
Report
- Report Number
- 1824206-2011-00902
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 4, 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 THE BED "DOWN" STORAGE. HEAD UP FUNCTION NOT WORKING MANUALLY OR UNDER POWER. BATTERY LED IS ON. AFTER TROUBLESHOOTING DETERMINED PROBLEM TO BE FAULTY VALVE GUIDE TUBE. REPLACED HEAD UP VALVE GUIDE TUBE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFORMATION ALLEGED THAT THE HEAD UP FUNCTION WAS NOT WORKING. FUNCTION DOSE NOT WORK MANUALLY OR UNDER POWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900C001566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |