BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3090759 · Received May 2, 2013

    Report

    Report Number
    1525712-2013-03462
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSIV-HD POWER CHAIR JOYSTICK THAT CAUSES THE CHAIR TO SURGE. THIS COULD CAUSE THE DEVICE TO HAVE ERRATIC MOVEMENT AND COULD CAUSE INJURY TO THE USER AND BYSTANDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192444 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other