FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1964509
·
Received December 22, 2010
Report
- Report Number
- 1824206-2010-11886
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE BED WOULD NOT GO INTO ETR. FOUND A PIECE OF GASKET IN THE MANIFOLD. REMOVED THE PIECE TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED ALLEGED THAT THE BED WOULD NOT LOWER THE HEAD WITH CPR AND WOULD NOT GO INTO ETR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900C002883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |