FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1954045
·
Received December 16, 2010
Report
- Report Number
- 1824206-2010-11662
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 22, 2010
- 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
THE TECH DETERMINED THE PROBLEM TO BE A FAULTY VALVE GUIDE TUBE. THE TECH REPLACED THE HEAD UP VALVE GUIDE TUBE TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE HEAD UP FUNCTION IS NOT WORKING. THE FUNCTION DOES NOT WORK MANUALLY OR UNDER POWER AND THE BATTERY LED IS ON.
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 |