FDA Adverse Event
Injury
Summary report: N
CENTRA BED
MDR report key: 1003963
·
Received February 8, 2008
Report
- Report Number
- 1824206-2008-00034
- Event Type
- Injury
- Date Received
- February 8, 2008
- Date of Event
- December 22, 2007
- Report Date
- January 31, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER REPORTED THAT A PT FELL AND FRACTURED THEIR HIP AS THEY WERE ADJUSTING THE BLANKET ON THE BED. THE BRAKES WERE SET AND THE FALL ALLEGEDLY OCCURRED DUE TO THE BED MOVING. THE HILL-ROM TECHNICIAN WENT TO THE FACILITY AND INSPECTED THE BED. HE FOUND THAT BED BRAKES DID NOT HOLD DUE TO BEING OUT OF ADJUSTMENT. HE FOUND THAT THE FACILITY WAS NOT PERFORMING YEARLY PREVENTATIVE MAINTENANCE ON THE BED AS OUTLINED IN THE SERVICE MANUAL. THE FACILITY HAS FILED A MEDWATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRA BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | 850 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |