FDA Adverse Event
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 3253153
·
Received July 29, 2013
Report
- Report Number
- 1531186-2013-03465
- Date Received
- July 29, 2013
- Report Date
- July 12, 2013
- Manufacturer
- LAND AMERICA HEALTH & FITNESS
- Product Code
- IKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Description of Event or Problem · 1
THE FACILITY IS REPORTING THAT THE CRANK HAS BROKEN OFF OF THE HI LOW FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352475 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | LAND AMERICA HEALTH & FITNESS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |