BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2990524 · Received March 5, 2013

    Report

    Report Number
    1525712-2013-01629
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER THE DEALER, THE CONSUMER'S MOTHER SAYS THAT THE CHAIR MOVES ON IT'S OWN. AS THE CHAIR GETS TURNED ON , IT SPORADICALLY MOVES BY ITSELF. THIS MORNING AS THE USER WAS GOING INTO THE BATHROOM, THE CHAIR CONTINUED MOVING AND HIT THE TOILET AND A CABINET. NO DAMAGE. WHEN IN TILT MODE, IT WILL SOMETIMES CONTINUE TO TILT ON ITS' OWN. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93619 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 14 Other