BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3163454 · Received June 11, 2013

    Report

    Report Number
    1525712-2013-04533
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE RIGHT MOTOR INTERMITTENTLY SHORTING AND CAUSING A BRAKE FAULT ON THE TDXSPREE POWER CHAIR. THIS EVENT COULD CAUSE THE PRODUCT TO MAKE UNINTENDED AND ERRATIC MOVEMENTS AND POSSIBLY CAUSE INJURY TO THE USER OR BYSTANDER, OR LEAVE THE USER STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264269 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSPREE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other