BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3150949 · Received June 6, 2013

    Report

    Report Number
    3004493922-2013-01213
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    FRAME BROKE ON BOTH SIDES OF THE SEAT POST TUBE, WHERE ATTACHED TO SIDE FRAMES. TOP SHROUD CRACKED FROM THE SEAT POST MOVING AND THE SIDE FRAMES STARTED LEANING TOWARDS EACH OTHER AND THE MOTOR BRAKES WERE TOUCHING, DAMAGING THE LEFT BRAKE. USER CONTINUED USING CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251727 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other