BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3011857 · Received March 19, 2013

    Report

    Report Number
    1525712-2013-02081
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE FDX-CG CUSTOM POWER WHEELCHAIR REAR CASTERS WHEEL WERE WOBBLY AND FLUTTERING WHEN GOING OVER AN UNEVEN GROUND AT A HIGH SPEED, AND IT DID NOT OCCUR WHEN DRIVING ON A SLOW SPEED. ADDITIONALLY, IT WAS REPORTED THAT ALLEGEDLY THE WOBBLING OF THE CASTER WHEELS HAD CAUSED HIM TO BUMP INTO WALLS. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113526 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Other