BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3112734 · Received May 14, 2013

    Report

    Report Number
    1525712-2013-03768
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE SOCKET PIVOT CUP FOR THE ARMREST ON AN R51LXP POWER CHAIR NOT BEING IN PLACE. THIS ALLOWS THE ARMREST TO FLIP ALL THE WAY BACK INSTEAD OF STOPPING, AND MAY CONTRIBUTE TO THE USER NOT BEING ABLE TO RETRIEVE THE ARMREST FOR THE NEEDED SIDE SUPPORT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211944 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51LXP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other