BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLI-OX

    MDR report key: 10718079 · Received October 22, 2020

    Report

    Report Number
    10718079
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    August 31, 2020
    Report Date
    October 14, 2020
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS TRANSPORTED ON A VENTILATOR TO CT WHEN AIRGAS INTELLI-OX TANK READ OXYGEN FAILURE. PATIENT SUBSEQUENTLY BEGAN TO DESATURATE INTO LOW 70% AND REQUIRED EMERGENT TANK SWITCH OUT. THE OLD AIRGAS INTELLI-OX TANK STILL SHOWED 75% FULL.

    Description of Event or Problem · 1

    PATIENT WAS TRANSPORTED ON A VENTILATOR TO CT WHEN AIRGAS INTELLI-OX TANK READ OXYGEN FAILURE. PATIENT SUBSEQUENTLY BEGAN TO DESATURATE INTO LOW 70% AND REQUIRED EMERGENT TANK SWITCH OUT. THE OLD AIRGAS INTELLI-OX TANK STIL SHLOWED 75% FULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182624 INTELLI-OX CYLINDER, COMPRESSED GAS, AND VALVE ECX AIR LIQUIDE HEALTHCARE AMERICA CORPORATION W0440226EE01

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA