BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINDE INTEGRATED VALVE - LIV

    MDR report key: 11607290 · Received April 2, 2021

    Report

    Report Number
    11607290
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 18, 2021
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LINDE LIV INTEGRATED VALVE OXYGEN SYSTEM (IT'S A PORTABLE OXYGEN TANK W/ REGULATOR) HAS 2 VALVES. ONE VALVE IS ON TOP AND ONE VALVE IS ON THE SIDE. BOTH VALVES NEED TO BE OPEN FOR OXYGEN TO FLOW. WHEN YOU OPEN THE TOP VALVE, THERE IS A HISSING NOISE WHICH CAN MISLEAD THE USER INTO THINKING THAT THE OXYGEN IS FLOWING AND FULLY TURNED ON. SUBSEQUENTLY, THEY MAY NOT OPEN THE SIDE VALVE BECAUSE THEY THINK THE OXYGEN IS ALREADY "ON." THIS DOES NOT SEEM TO BE A SAFE PRODUCT DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505476 LINDE INTEGRATED VALVE - LIV CYLINDER, COMPRESSED GAS, AND VALVE ECX LINDE LIV INTEGRATED VALVE OXYGEN SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1