BEUDAMED
    FDA Adverse Event Summary report: N

    ANESTHESIA MACHINE OXYGEN FLOW METER

    MDR report key: 13038 · Received April 22, 1994

    Report

    Report Number
    MW4000366
    Date Received
    April 22, 1994
    Report Date
    March 17, 1994
    Manufacturer
    NORTH AMERICAN DRAGER
    Product Code
    BSZ
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIRTEEN FLOWMETERS WERE RETURNED TO CO'S QUALITY ENGINEERING DEPT FOR ANALYSIS. OF THESE THIRTEEN FLOWMETERS, ELEVEN WERE CONSTRUCTED WITH BRASS VALVE BODIES, ONE WAS OF A STAINLESS STEEL VALVE CONSTRUCTION, AND ONE WAS AN OLDER STYLE MOLDED TUBE FLOWMETER. SIX OF THE BRASS VALVES WERE DISCOVERED TO NOT SHUT OFF COMPLETELY. THE BALANCE OF VALVES FUNCTIONED PROPERLY. THE FAILURE MECHANISM IN EACH OF THE SIX LEAKY VALVES WAS FOUND TO BE ATTRIBUTED TO GALLING AT THE SEALING POINT OF THE BRASS VALVE BODY. THIS GALLING IS CAUSED WHEN BRASS PARTICLES IMBED INTO THE SURFACE AT THE SHUT-OFF POINT, AND IS AGGRAVATED WHEN ADD'L ROTATIONAL FORCE IS APPLIED TO THE VALVE IN AN EFFORT TO STOP ALL FLOW OF OXYGEN. THE AUXILIARY OXYGEN FLOWMETER LEAKS WERE CAUSED BY GALLING AND SUBSEQUENT DETERIORATION OF THE SEALING ARA OF THE VALVE. THIS CONDITION HAS BEEN DETERMINED TO BE DIRECTLY RELATED TO THE MATERIAL AND CONSTRUCTION OF THIS VALVE, AND HAS BEEN CORRECTED BY A CHANGE IN VALVE MATERIAL TO STAINLESS, COMBINED WITH A DESIGN MODIFICATION TO THE PROFILE OF THE SEALING POINT (SEAT) OF THE VALVE. THESE CHANGES WERE EFFECTED WITH ECR 93-0166, WHICH WAS RELEASED 4/6/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA MACHINE OXYGEN FLOW METER BSZ NORTH AMERICAN DRAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 *