BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1930363 · Received November 18, 2010

    Report

    Report Number
    3004531588-2010-00128
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 18, 2010
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED THAT INOMAX DS, # (B)(4) HAD FLUCTUATING NITRIC OXIDE (NO) VALUES WHILE ON A PT. THE DEVICE IS IN TRANSIT FOR INVESTIGATION. THE SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED INOMAX DS DEVICE # (B)(4) WAS SET AT 20 PARTS PER MILLION (PPM) OF NITRIC OXIDE (NO) AND HAD MONITORED VALUES OF MINUS 5 TO 30 PPM WHILE ON A PT. LOW AND HIGH CALIBRATIONS WERE COMPLETED AND THE VALUES STABILIZED FOR ABOUT AN HOUR AND THEN MONITORED VALUES BEGAN TO FLUCTUATE BETWEEN 7 TO 26 PPM. THE INJECTOR MODULE (IM) AND DISPOSABLES WERE CHANGED WITHOUT IMPROVEMENT. THE DEVICE WAS SWITCHED OUT, AND THE RESPIRATORY THERAPIST REPORTED THERE WAS NO HARM TO THE PT AND NO ADVERSE EVENT HAD OCCURRED. THE FOLLOWING DAY, THE DEVICE WAS TESTED ON ROOM AIR AND THE VALUES WERE STABLE, BUT THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO THE COMPANY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1