BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAXDS

    MDR report key: 3682708 · Received March 11, 2014

    Report

    Report Number
    3682708
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 24, 2014
    Report Date
    March 4, 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

    PATIENT WAS ON 40PPM OF NO. THE INO VENT BEGAN TO ALARM DUE TO ONLY READING 20PPM. I RE-CALIBRATED THE INO VENT AND IT FAILED DUE TO "FAILURE OF FUEL CELL". I CALLED OUR CHARGE RT TO BRING A NEW INO VENT, WHICH SHE BROUGHT QUICKLY. WE SWITCHED OUT THE INO VENT WITH NO ISSUE. PT TOLERATED ALL OF THIS WITHOUT ANY SIGNS OF DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146216 INOMAXDS APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA, INOMAXDS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY NOT APPLICABLE.