FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2170811
·
Received June 22, 2011
Report
- Report Number
- 1824206-2011-03374
- 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 THE BED IN "DOWN" STORAGE AREA. FOUND HEAD OF BED WAS DRIFTING DOWN SLOWLY DUE TO FAULTY CPR VALVE. REPLACED CPR VALVE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
BED FOUND IN "DOWN" STORAGE AREA. CAUSE OF PROBLEM IS UNKNOWN. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | TOTAL CARE | FNL | HILL-ROM INC. | P1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |