BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIV

    MDR report key: 4901766 · Received June 15, 2015

    Report

    Report Number
    4901766
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 10, 2015
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OXYGEN TANK ON CRASH CART MALFUNCTIONED FOR USE WITH CODE BLUE. GAUGE ON O2 TANK READ "FULL" VALVE WAS "OPEN" AND THE OXYGEN DIAL FOR SELECTING LITERS/MIN WAS FULLY TURNED UP TO THE MAX (15L/M). HOWEVER, NO OXYGEN FLOWED FROM REGULATOR OF TANK. MULTIPLE ATTEMPTS WERE MADE TO REOPEN AND CLOSE VALVE AND LITERS/MIN TO TRY TO OPEN THE OXYGEN TANK WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387941 LIV CYLINDER, COMPRESSED GAS, AND VALVE ECX LINDE GAS NORTH AMERICA LLC LIV 2000 201209 35

    Patients

    Seq Age Sex Outcome Treatment
    1 *