FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-
MDR report key: 2220133
·
Received August 15, 2011
Report
- Report Number
- 1824206-2011-04296
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 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 - CAUSE OF PROBLEM UNK. BED FOUND IN "DOWN" STORAGE. HEAD UP FUNCTION WAS NOT WORKING. FUNCTION DOES NOT WORK MANUALLY OR UNDER POWER. BATTERY LED IS ON. DETERMINED PROBLEM TO BE FAULTY VALVE GUIDE TUBE. REPLACED HEAD UP VALVE GUIDE TUBE TO RESOLVE THIS ISSUE. BED FUNCTIONS PROPERLY.
Description of Event or Problem · 1
INFO PROVIDED INDICATED THAT THE HEAD UP FUNCTION WAS NOT WORKING. 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 |