FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1905686
·
Received November 12, 2010
Report
- Report Number
- 1824206-2010-10991
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 19, 2010
- Report Date
- October 19, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE CPR VALVE TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED, THE HEAD SECTION CANNOT BE RAISED FROM THE SIDERAIL SWITCHES OR MANUALLY. THE ACCOUNT HAS REPLACED THE HEAD UP AND DOWN VALVES BUT THE ISSUES REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |