FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE SPORT BED
MDR report key: 3002702
·
Received February 13, 2013
Report
- Report Number
- 1824206-2013-00984
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- 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 TECH REPLACED THE SIDE RAIL CABLE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED THAT THE MATTRESS THERAPY ON THE BED WOULD NOT FUNCTION DUE TO THE SIDE RAIL CABLE HAVING BARE METAL WIRES EXPOSED. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63710 | TOTALCARE SPORT BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900F100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |