BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEMS)

    MDR report key: 1922626 · Received November 12, 2010

    Report

    Report Number
    3004531588-2010-00119
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 12, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED INOMAX DS (B)(4) HAD A NITRIC OXIDE (NO) CELL FAILURE WITH GROSSLY FLUCTUATING NO LEVELS. 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 (B)(4), WHILE ON A PT, HAD A NITRIC OXIDE (NO) CELL FAILURE WITH GROSSLY FLUCTUATING NO LEVELS. THE RESPIRATORY THERAPIST STATED THERE WAS NO EFFECT TO THE PT AND NO ADVERSE EVENT OCCURRED. THE RESPIRATORY THERAPIST PERFORMED BOTH LOW AND HIGH CALIBRATIONS ON THE DEVICE WITHOUT EFFECT. 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 SYSTEMS) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS, LLC/IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1