FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1961284
·
Received December 20, 2010
Report
- Report Number
- 1824206-2010-11761
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT FOUND THE MANIFOLD RUNS, BUT NO HEAD UP MOVEMENT. TECHNICIAN INFORMED THE ACCOUNT TO SWAP COILS WITH WIRES ATTACHED TO ISOLATE AND ALSO TRY THE MANUAL FOOT PUMP TO ISOLATE THE ISSUE. CHECK THE HEAD UP OR HEAD DOWN VALVES AND CARDIO PULMONARY RESUSCITATION VALVE TO ISOLATE THE ISSUE. ACCOUNT FOUND THE HEAD WOULD NOT RAISE MANUALLY OR ELECTRICALLY. ACCOUNT REPLACED THE HEAD UP VALVE SOLENOID TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THE HEAD OF THE BED DOES NOT RAISE. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |