FDA Adverse Event
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 3024283
·
Received March 27, 2013
Report
- Report Number
- 1531186-2013-01310
- Date Received
- March 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- LAND AMERICA HEALTH & FITNESS
- Product Code
- IKZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES THE MIDDLE OF THE SPRING DECK ON HIS BED BOWED. CONSUMER ALLEGES THAT THE SPRINGS ARE NOT AS HIGH IN THE MIDDLE AS THEY ARE ON EITHER END OF THE SPRING DECK. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126393 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | LAND AMERICA HEALTH & FITNESS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Congenital Anomaly| O |