BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WESTERN MEDICA MEDICAL OXYGEN PRESET REGULATOR

    MDR report key: 3753560 · Received January 10, 2014

    Report

    Report Number
    1526809-2014-00001
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    July 30, 2012
    Report Date
    December 13, 2013
    Manufacturer
    WESTERN/SCOTT FETZER CO.
    Product Code
    CAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE M1-540-P IS A SINGLE STAGE, PRESET OXYGEN REGULATOR WITH MAXIMUM INLET PRESSURE OF 3000 PSI. THE OUTLET PRESSURE IS FACTORY PRESET TO DELIVER OUTLET PRESSURE WHEN THE SUPPLY (I.E., TANK) IS TURNED ON (I.E. DELIVERS 50-56 PSI AT A SUPPLY PRESSURE OF 2000-2200 PSI). THE MODEL HAS ONE, 2" DIAMETER GAUGE (I.E., BOURDON TUBE GAS PRESSURE GAUGE), WHICH DISPLAYS THE GAS PRESSURE SUPPLIED TO THE REGULATOR. THE CUSTOMER REPORTED THAT THE "TANK WAS EMPTY DESPITE REGULATOR GAUGE REFLECTING APPROXIMATELY 800-900 LBS OF PRESSURE." RECORDS INDICATE THE SUBJECT DEVICE SHIPPED FROM WESTERN TO THE CUSTOMER ON (B)(6) 2011. THE SUBJECT DEVICE WAS NOT RETURNED TO WESTERN FOR EVALUATION, BUT IS BEING RETAINED BY THE CUSTOMER'S ATTORNEYS. WITHOUT PHYSICAL EVALUATION, THE ACTUAL CAUSE OF THE ALLEGED DISCREPANCY CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ACCORDING TO INFORMATION PROVIDED BY THE INITIAL REPORTER: OXYGEN REGULATOR GAUGE SHOWED APPROXIMATELY 1000 LBS OF PRESSURE IN OXYGEN TANK BEFORE USE. DURING USE, FLOW CEASED AND ALTERNATE TANK WAS UTILIZED. ASSESSMENT OF OXYGEN TANK AND GAUGE AFTER EVENT REVEALED TANK WAS EMPTY DESPITE REGULATOR GAUGE REFLECTING APPROXIMATELY 800-900 LBS OF PRESSURE. PLAINTIFFS ALLEGE CARDIAC ARREST AND BRAIN INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18636 WESTERN MEDICA MEDICAL OXYGEN PRESET REGULATOR CAN WESTERN/SCOTT FETZER CO. M1-540-P

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Disability