FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2050845
·
Received April 4, 2011
Report
- Report Number
- 1824206-2011-01998
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE MATTRESS TICKING AND THE FOAM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE MATTRESS TICKING HAD A TEAR IN IT AND FLUID HAD GOTTEN ON THE FOAM. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |