FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2901899
·
Received November 21, 2012
Report
- Report Number
- 1824206-2012-07614
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 31, 2012
- Report Date
- October 31, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN TESTED THE BED EXIT ALARM AND FOUND THE BED ALARMED PROPERLY. IT WAS NOTED THAT THE LEFT HAND BED EXIT INDICATOR DID NOT ILLUMINATE.
Description of Event or Problem · 1
ACCOUNT ALLEGED THE PT GOT OUT OF BED FELL. THE BED EXIT DID NOT ALARM. THERE WERE NO INJURIES REPORTED.
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 |