BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLI-OX

    MDR report key: 17585951 · Received August 18, 2023

    Report

    Report Number
    MW5144785
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 16, 2023
    Manufacturer
    AIRGAS USA LLC / AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS PLACED ON 6L HIGH FLOW ON THE PORTABLE TANK. DURING TRANSPORT, TRANSPORT STAFF FLAGGED DOWN NURSING STAFF AS PATIENT WAS BECOMING LESS RESPONSIVE AND DUSKY IN COLOR ENROUTE. PATIENT PUT ON MONITOR SHOWING DESATURATION. SWITCHED TO WALL O2 AND PUT ON FACE MASK. PATIENT'S OXYGENATION QUICKLY IMPROVED. IT WAS NOTED THAT THE PORTABLE O2 TANK WAS SHOWING FULL BUT NO O2 IS COMING OUT, NO MATTER HOW MANY LITERS IT IS SET TO. DEVICE WAS TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035145 INTELLI-OX CYLINDER, COMPRESSED GAS, AND VALVE ECX AIRGAS USA LLC / AIR LIQUIDE HEALTHCARE AMERICA CORPORATION N4493 165 XE 19

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention