BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3935139 · Received July 15, 2014

    Report

    Report Number
    1525712-2014-03685
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 9, 2014
    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

    IT WAS REPORTED THAT THE TDXSC2-CG POWER CHAIR KEEPS GOING INTO A PARK BRAKE FAULT. THE PROVIDER STATES THE END USER WAS OUT WHEN THIS ISSUE OCCURRED AND HAD TO BE PUSHED HOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412346 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSC2-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other