BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3024161 · Received March 27, 2013

    Report

    Report Number
    1525712-2013-02340
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATES HE HAD AN E1, E9, AND E200 FAULT CODE. HE STATES HE WANTS A NEW JOYSTICK. SPOKE WITH DEALER ABOUT THE ACTUAL PROBLEMS WITH THE CHAIR AND HE STATES IT CHANGES MODES ALL ON IT'S OWN. HE STATES DRIVE ONE IS DRIVING, DRIVE 4 IS SEATING. HE STATES IT'S CHANGING FROM DRIVING AND IT SKIPS OVER DRIVE 2&3. HE STATES HE DID NOT WITNESS THIS PROBLEM HIMSELF. HE STATES WHEN IT WENT TO DRIVE 4 THE SEATING WOULD NOT WORK. IF HE PUTS IT INTO SEATING ON HIS OWN THE TILT WORKS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126898 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other