FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2220475
·
Received July 18, 2011
Report
- Report Number
- 1824206-2011-03783
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- June 28, 2011
- Report Date
- June 28, 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 IN "DOWN" STORAGE. FOUND: - HEAD UP FUNCTION NOT WORKING DUE TO FAULTY VALVE GUDE TUBE. FUNCTION DOES NOT WORK MANUALLY OR UNDER POWER. BATTERY LED WAS ON. REPLACED THE HEAD UP VALVE GUIDE TUBE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THAT THE HEAD UP FUNCTION WAS NOT WORKING ON THIS BED. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |