BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2996141 · Received March 10, 2013

    Report

    Report Number
    1525712-2013-01816
    Event Type
    Malfunction
    Date Received
    March 10, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    1 OF 2 SCREWS ( NO INDIVIDUAL PART # . IS IN SAME KIT 1140424) WHICH ATTACHES THE QUAD LINK TO THE JOYSTICK TUBE FELL OUT. THE REMAINING SCREW STAYED IN PLACE. JOYSTICK AND QUADLINK STAYED ON CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100885 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51LXP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other