FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-
MDR report key: 2170813
·
Received June 22, 2011
Report
- Report Number
- 1824206-2011-03375
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 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 BED IN "DOWN" STORAGE. HEAD UP FUNCTION NOT WORKING 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.
Description of Event or Problem · 1
CAUSE OF PROBLEM UNKNOWN. BED FOUND IN "DOWN" STORAGE AREA. NO PT IMPACT REPORTED.
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 |