BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM

    MDR report key: 14073321 · Received April 11, 2022

    Report

    Report Number
    14073321
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    February 27, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ESSEX INDUSTRIES, INC.
    Product Code
    BYJ
    UDI-DI
    10815363020025
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LIQUID OXYGEN SYSTEM FAILED, RAN COMPLETELY OUT OF OXYGEN 90 MINUTES INTO A PATIENT FIXED WING TRANSPORT WITH 90 PLUS MINUTES OF THE TRANSPORT REMAINING. THE PATIENT WAS ON ECMO, SO BOTH THE ECMO DEVICE AND VENTILATOR WERE USING OXYGEN. THE CREW HAD TO DIVERT THE FLIGHT TO THE CLOSEST ECMO CAPABLE CENTER AND MANAGE THE PATIENT ON A PORTABLE OXYGEN CYLINDER ON THE AIRCRAFT UNTIL MET AT THE AIRPORT. THE ESSEX INDUSTRIES, INC 10 LITER LIQUID OXYGEN CONVERTOR SYSTEM HAD A PRESSURE RELEASE VALVE/VENT FAILURE SOMETIME DURING THE COURSE OF THE TRANSPORT AND LOST ALL OXYGEN. SENT BACK TO MFG. FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445072 PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM UNIT, LIQUID-OXYGEN, PORTABLE BYJ ESSEX INDUSTRIES, INC. 50C-0021-1 10815363020025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown