BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3951865 · Received July 23, 2014

    Report

    Report Number
    1525712-2014-03908
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 17, 2014
    Manufacturer
    UNKNOWN
    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 DEALER, AT 5 LPM IT IS GOING HIGH THEN LOW ON THE CONCENTRATION. NEEDS PE VALVE, IS SHUTTING DOWN AT 45 MINS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430643 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other