BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2991892 · Received March 6, 2013

    Report

    Report Number
    3004493922-2013-00541
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEALER STATES CHAIR WAS VEERING AND JOYSTICK WAS HARD TO TURN ON AND OFF. NEW INT CONTROLLER/JOYSTICK APPEARS TO HAVE WRONG PROGRAMMING IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96345 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other