FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2191758
·
Received July 28, 2011
Report
- Report Number
- 1824206-2011-03996
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 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 IN "DOWN" STORAGE AREA. FOUND HEAD HI-LO DRIFTS DOWN SLOWLY DUE TO FAULTY EMERGENCY TREND VALVE. REPLACED EMERGENCY TREND VALVE TO RESOLVE THIS PROBLEM.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT THE HEAD HI-LO WOULD DRIFT DOWN SLOWLY. NO INJURY REPORTED.
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 |