BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX

    MDR report key: 4205792 · Received October 6, 2014

    Report

    Report Number
    4205792
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    June 5, 2014
    Report Date
    October 2, 2014
    Manufacturer
    INO THERAPEUTICS, LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RT ARRIVED TO TURN ON NITROUS OXIDE (NO) MACHINE, BUT THE NITRIC BUTTON ON THE TOUCH SCREEN WOULD NOT WORK. THEREFORE WE WERE UNABLE TO DELIVER ON TO THE PATIENT, AND ANOTHER MACHINE HAD TO BE BROUGHT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625050 INOMAX APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS, LLC/DBA IKARIA UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO