BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3051677 · Received April 10, 2013

    Report

    Report Number
    3004493922-2013-00786
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER'S SON STATES CONSUMER IS HITTING JOYSTICK W/ELBOW AND CHAIR TURNS ON CAUSING HER TO FALL OUT OF CHAIR. TWICE IT HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148331 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR16B

    Patients

    Seq Age Sex Outcome Treatment
    1 91 Other