BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3250159 · Received July 26, 2013

    Report

    Report Number
    1525712-2013-06225
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES SEAT MAKES AN AWFUL BUZZING NOISE. SEAT WILL MOVE UP AND DOWN FREELY WITHOUT ACTUATOR ATTACHED. NOTHING SEEMS NOT TO BE BINDING. ONLY HAPPENS WHEN GET TO HALF WAY POINT OF TILT WITH WEIGHT IN CHAIR AND GETS LOUDER THE MORE YOU TILT BACK. THIS IS A SECOND ACTUATOR IN TWO WEEKS. FIRST REPLACEMENT WORKED FOR A WEEK OR MORE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351617 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other