BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3163581 · Received June 11, 2013

    Report

    Report Number
    3004493922-2013-01252
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE JOYSTICK ON AN M41 POWER CHAIR DISPLAYING FLASH CODES AND THE CHAIR IS NOT TURNING OFF. THE CHAIR NOT TURNING OFF CREATES THE POTENTIAL FOR UNINTENDED MOVEMENT WHEN THE USER ATTEMPTS TO ENTER OR EXIT THE CHAIR. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264010 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other