FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 1920917
·
Received December 6, 2010
Report
- Report Number
- 1824206-2010-11416
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE BED SHEET WAS OBSTRUCTING THE SIDERAIL LATCH WHICH PREVENTED THE SIDERAIL FROM LATCHING.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE RAILS ON THE BED WILL NOT STAY UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |