BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3022160 · Received March 26, 2013

    Report

    Report Number
    1525712-2013-02334
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THE FOUR-WAY TOGGLE SWITCH WAS CAUSING THE TILT ACTUATOR TO GO INTO THE UPRIGHT POSITION. THE ACTUATOR WOULD CONTINUE TO RUN UNTIL THEY UNPLUGGED THE TOGGLE SWITCH OR TURNED OFF CHAIR. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123630 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSPREE-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other