BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3944261 · Received July 18, 2014

    Report

    Report Number
    1525712-2014-03793
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    CAREGIVER STATES THAT THE ATTENDANT CONTROL CANNOT BE PUT IN MANUAL. WHEN PRESSING THE RESET BUTTON NOTHING HAPPENS. CAREGIVER BELIEVES THERE IS A WIRE NOT CONNECTED BUT THEY DO NOT KNOW WHERE IT GOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423002 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDX3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other