BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX INOVENT

    MDR report key: 3890021 · Received June 10, 2014

    Report

    Report Number
    3890021
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DELIVERY FAILURE FOR THE NITRIC MACHINE. INFRARED NOT READING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343406 INOMAX INOVENT APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO