FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2800320
·
Received October 9, 2012
Report
- Report Number
- 1824206-2012-06262
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Date of Event
- September 19, 2012
- Report Date
- September 20, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND A WORN AND STAINED HEAD AND P/V CUSHION DUE TO FLUID INGRESS. HE INSTALLED A TICKING REFIRB KIT ALONG WITH REPLACING THE HEAD AND P/V CUSHION.
Description of Event or Problem · 1
INFO RECEIVED INDICATED FLUID INGRESS WAS FOUND IN THE MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |