FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3011866
·
Received March 19, 2013
Report
- Report Number
- 1525712-2013-02085
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Report Date
- February 20, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- 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
THE DEALER REPORTED THAT THERE WAS STRAIN RELIEF WHERE THE WIRING FOR THE JOYSTICK IS PARTIALLY PULLED OUT, EFFECTING THE PROGRAMMING. THIS CREATES THE POTENTIAL FOR THE USER TO BECOME STRANDED OR SUTCK IN AN UNWANTED POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113528 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |