BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (IR)

    MDR report key: 2800860 · Received October 17, 2012

    Report

    Report Number
    2800860
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 28, 2012
    Manufacturer
    IKARIA, INC.
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE INHALED NITRIC OXIDE (INO) DELIVERY FAILURES OCCURRED WHILE SUCTIONING PATIENT IN TANDEM WITH THE HIGH FREQUENCY JET VENTILATION (HFJV).THE SITUATION REQUIRED ADDITIONAL AND PROLONGED BAGGING VIA INO BLENDER, REPOWERING THE INO UNIT, AND WAITING FOR THE SELF TEST SCREEN TO COMPLETE ITS OPERATION BEFORE REDIALING THE NITRIC SETTING TO 20PPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (IR) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO