FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1951241
·
Received December 14, 2010
Report
- Report Number
- 1824206-2010-11584
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND THAT THE HEAD HI-LO PORTION OF THE BED WAS DRIFTING DOWN. REPLACED THE HEAD HI-LO VALVE GUIDE TUBE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THAT THE HEAD HI-LO PORTION OF THE BED WAS LOWER THAN THE FOOT PORTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900K006837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |