FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2974735
·
Received January 18, 2013
Report
- Report Number
- 1824206-2013-00513
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 15, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH REPLACED THE HEAD DOWN VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED THE HEAD OF THE BED WOULD DRIFT DOWN SLOWLY OVER TIME. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28784 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |