BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3832028 · Received May 27, 2014

    Report

    Report Number
    3004493922-2014-00788
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE CHAIR SEIZED UP AND CAUSED THE END USER TO FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310523 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 Other