BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3062137 · Received April 16, 2013

    Report

    Report Number
    1525712-2013-02918
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSP-MCG POWER CHAIR WITH A JOYSTICK THAT IS UNRESPONSIVE WHILE TURNING. THIS EVENT COULD CAUSE ERRAIC/UNINTENDED MOVEMENT WHICH COULD INJURE A USER OR BYSTANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162188 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other