BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3964386 · Received July 29, 2014

    Report

    Report Number
    1031452-2014-04627
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, STATES THE UNIT WILL BEGIN ALARMING AND SHUT DOWN AFTER THIRTY MINUTES OF RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440770 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other