FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1981295
·
Received February 2, 2011
Report
- Report Number
- 1824206-2011-00603
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 19, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE UNIT HEAD WAS NOT GOING UP OR DOWN. REPLACED HEAD UP/DOWN MODULES TO RESOLVE ISSUE.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT THE HEAD SECTION WAS NOT RAISING UP NOR DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1840ARE0001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |