BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYTOTE PORTABLE OXYGEN SYSTEM

    MDR report key: 4129360 · Received September 18, 2014

    Report

    Report Number
    1526809-2014-00004
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    WESTERN/SCOTT FETZER CO.
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORT ALLEGES AN OXYTOTE PORTABLE OXYGEN SYSTEM, CONSISTING OF A VALVE INTEGRATED PRESSURE REGULATOR (OR VIPR) MOUNTED TO AN ALUMINUM OXYGEN CYLINDER, WHICH IS USED FOR OXYGEN THERAPY. AT THIS TIME, NO PRODUCT WAS RETURNED FOR EVALUATION, THEREFORE, POSITIVE IDENTIFICATION OF THE SUBJECT DEVICE HAS NOT YET BEEN ESTABLISHED.

    Description of Event or Problem · 1

    AS REPORTED TO WESTERN, AN EMPLOYEE WAS REFILLING A 23 CUBIC FOOT ALUMINUM LUXFER CYLINDER WITH OXYGEN AND BUMPED IT ON SOMETHING. AFTER THAT, IT EXPLODED AND RESULTED IN THE DEATH OF THE EMPLOYEE. IT WAS REPORTED THAT THE CYLINDER WAS MANUFACTURED IN 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579863 OXYTOTE PORTABLE OXYGEN SYSTEM REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER CO. VLB-603H; VLB-600L

    Patients

    Seq Age Sex Outcome Treatment
    1 Death