FDA Adverse Event
Malfunction
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 3181048
·
Received June 20, 2013
Report
- Report Number
- 1031452-2013-01158
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 24, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- IKZ
- 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
PROVIDER STATES THE HEAD AND FOOT OF BED WILL RAISE, BUT WILL GO BACK DOWN AGAIN ON THEIR OWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280869 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | INVACARE FLORIDA OPERATIONS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |