BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM ONE

    MDR report key: 1011230 · Received February 4, 2008

    Report

    Report Number
    1011230
    Event Type
    Malfunction
    Date Received
    February 4, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 4, 2008
    Manufacturer
    PRAXAIR, INC.
    Product Code
    BYJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE O2 REGULATOR REGISTERED AT ZERO WHEN IN FACT IT WAS FULL . WHEN WE SWITCHED OUT TANKS, IT WAS DISCOVERED THAT THE SAME PROBLEM WAS IDENTIFIED IN EIGHT TANKS. THE COMPANY WAS CONTACTED AND REPLACEMENT TANKS WERE PROVIDED. SIXTEEN TANKS HAD THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM ONE REGULATOR, OXYGEN, E CYLINDER SYSTEM BYJ PRAXAIR, INC. FREEDOM ONE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR