FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1944827
·
Received December 10, 2010
Report
- Report Number
- 1824206-2010-11523
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 16, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE TREND DOWN VALVE IS DEFECTIVE. HE REPLACED THE TREND VALVE ASSEMBLY TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE HEAD HI/LOW FUNCTION IS DRIFTING DOWN VERY SLOW OVER TIME.
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 |