BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4182492 · Received October 17, 2014

    Report

    Report Number
    1525712-2014-07053
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 29, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER ALLEGED THAT ON THE PROPORTIONAL ATTENDANT CONTROL, THE DIAL FEELS ROUGH AND WHEN IT CLICKS, IT CLICKS TO THE OFF POSITIONS. FEELS LIKE IT MAY BE LOOSE. WHEN IN ON POSITION, WHEN IT IS TOUCHED IT WILL BE IN OCCUPANT DRIVE MODE, NOT ATTENDANT DRIVE MODE, IT SWITCHES BACK AND FORTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660404 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other