FDA Adverse Event
Malfunction
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 3083683
·
Received April 29, 2013
Report
- Report Number
- 1031452-2013-00813
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 3, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- IKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.END USER STATES THE BED ENDS WILL NOT MOVE WITH THE CRANK.MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184446 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | INVACARE FLORIDA OPERATIONS | 5890IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |