FDA Adverse Event
Malfunction
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 3092829
·
Received May 3, 2013
Report
- Report Number
- 1031452-2013-00839
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Report Date
- April 9, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- IKZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CONSUMER ALLEGES THAT WHILE CRANKING THE BED, THE HAND CRANK BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194022 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | INVACARE FLORIDA OPERATIONS | VCPKGIVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |