BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVENT

    MDR report key: 4208977 · Received October 10, 2014

    Report

    Report Number
    4208977
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    October 10, 2014
    Manufacturer
    INO THEREPEUTICS 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

    INOVENT MACHINE ALARMED "CYLINDER NOT DETECTED," AND "CYLINDER VALVE CLOSED." NITRIC WAS NOT DELIVERED TO THE PATIENT. PATIENT SATURATION DROPPED FROM 92% TO 84%. THE ISSUE WAS RESOLVED QUICKLY AND PATIENT RECOVERED SUCCESSFULLY. INOVENT MACHINE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643243 INOVENT APPARATUS, NITRIC OXIDE DELIVERY MRN INO THEREPEUTICS LLC/DBA IKARIA INOMAXDSIR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR