FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1953887
·
Received December 15, 2010
Report
- Report Number
- 1824206-2010-11609
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND A FAULTY HEAD UP SOLENOID VALVE. REPLACED THE VALVE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFO RECEIVED ALLEGED THAT THE HEAD SECTION WOULD NOT RAISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900E005054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |