FDA Adverse Event
Malfunction
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 2902334
·
Received January 8, 2013
Report
- Report Number
- 1031452-2013-00055
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- IKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DRIFTS DOWN PER PROVIDER. MDR FILED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9753 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | INVACARE FLORIDA OPERATIONS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |