BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN E-CYLINDER

    MDR report key: 6431421 · Received March 24, 2017

    Report

    Report Number
    6431421
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    April 27, 2016
    Report Date
    March 17, 2017
    Manufacturer
    LINDE GAS NORTH AMERICA LLC LIFEGAS
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC CAP WAS REMOVED FROM THE REGULATOR ON A NEW/FULL E-CYLINDER PSI READ 2000. AFTER 15 MINUTES ON FLOW RATE OF 15 LITER PER MINUTES (L/M) THE RESERVOIR BAG BECAME FLAT. THE REGULATOR NOW READ EMPTY. PATIENT VENTILATED BY BAG AND PLACED ON WALL O2; NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214769 OXYGEN E-CYLINDER CYLINDER, COMPRESSED GAS, AND VALVE ECX LINDE GAS NORTH AMERICA LLC LIFEGAS 084H607

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other