FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2912554
·
Received January 13, 2013
Report
- Report Number
- 3004493922-2013-00103
- Event Type
- Malfunction
- Date Received
- January 13, 2013
- Report Date
- January 13, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES THAT WHEN THE JOYSTICK IS IN REVERSE, IT DOES NOT WORK WHEN YOU GO TO PULL BACK TO THE LEFT OR RIGHT. IT TAKES OFF GOING BACKWARDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19483 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE SUZHOU | M41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |