BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR

    MDR report key: 5069847 · Received September 11, 2015

    Report

    Report Number
    5069847
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    February 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NITRIC OXIDE MACHINE DISPLAYED MESSAGE ON SCREEN: "FAILED NITRIC OXIDE CELL." PER RT THIS MEANT THE PATIENT WAS NOT RECEIVING ANY NITRIC OXIDE TO THE MACHINE, NEEDED TO BE SWITCHED OUT. UPON SWITCHING OUT THE MACHINE, PATIENT STARTED GASPING FOR AIR, LOST A BP AND CODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602038 INOMAX DSIR APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR