BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1924471 · Received December 7, 2010

    Report

    Report Number
    3004531588-2010-00133
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 7, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THE INOMAX DS (B)(4) STOPPED WORKING WHILE ON A PT, AND THE DEVICE SCREEN APPEARED BLACK WITH A YELLOW TRIANGLE ON IT. THE DEVICE INVESTIGATION IS COMPLETE AND IS THE FOLLOWING: THE ROOT CAUSE IS A SOFTWARE SYSTEM ERROR CAUSED BY A SEGMENTATION FAULT AT BOOT COUNT 15. THE DEVICE FUNCTIONED AS DESIGNED TO INTERRUPT NITRIC OXIDE DELIVERY AND ALARM WHEN SUCH AN ERROR IS DETECTED. THE CORRECTIVE ACTION WAS TO REPLACE THE MAIN CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST (RT) REPORTED INOMAX DS DEVICE (B)(4) STOPPED WORKING WHILE ON A PT, AND THE DEVICE SCREEN APPEARED BLACK WITH A YELLOW TRIANGLE ON IT. THE PT WAS A MALE INFANT (B)(6) WHO STARTED INOMAX FOR AN UNK INDICATION, ON (B)(6) 2010 AROUND 2300 AT 20 PARTS PER MILLION (PPM). THE INFANT'S BASELINE OXYGEN SATURATION LEVEL WAS AROUND 94%. WHEN THE INOMAX DS STOPPED WORKING ON (B)(6) 2010, THE PT EXPERIENCED AN OXYGEN SATURATION DECREASE TO THE LOW 80% RANGE FOR APPROX 30 SECONDS. AS SOON AS THE DESATURATION OCCURRED, THE RT INCREASED THE INFANT'S FRACTION OF INSPIRED OXYGEN (FIO2) TO 100% AND THE INFANT'S OXYGEN SATURATION INCREASED TO 85% IMMEDIATELY. THE RT THEN REMOVED THE INFANT FROM THE HIGH FREQUENCY VENTILATOR AND BEGAN MANUALLY VENTILATING THE INFANT WITH THE INOBLENDER FOR A FEW MINUTES WHILE ANOTHER THERAPIST TURNED THE INOMAX DS OFF AND THEN BACK ON AGAIN, AT WHICH TIME, IT FUNCTIONED NORMALLY. AS SOON AS MANUAL VENTILATION WITH THE INOBLENDER WAS INITIATED, THE INFANT'S OXYGEN SATURATION LEVEL RETURNED TO HIS BASELINE OF 94%. THE INFANT WAS RECONNECTED TO THE VENTILATOR SYSTEM WITHOUT FURTHER INCIDENT. THE INFANT REMAINS ON THE INOMAX DS (B)(4); HOWEVER, THE RT REQUESTED AS A PRECAUTION THE DEVICE BE SWITCHED OUT WHEN ANOTHER DEVICE IS AVAILABLE. THE REPORTER DEEMS THE EVENT OF OXYGEN DESATURATION FOR 30 SECONDS AN MILD, NON - SERIOUS AND DEFINITELY RELATED TO DEVICE MALFUNCTION CAUSING AN INTERRUPTION IN INOMAX THERAPY.

    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 Other