BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2063261 · Received March 22, 2011

    Report

    Report Number
    3004531588-2011-00014
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 22, 2011
    Manufacturer
    INO THERAPEUTICS, LLC/ IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 A RESPIRATORY THERAPIST REPORTS THE INOMAX DS, (B)(4) WENT INTO SYSTEM FAILURE. INVESTIGATION RESULTS RECEIVED ON (B)(4), 2011. THE DEVICE INVESTIGATION IS COMPLETE AND RESULTS FOLLOW: THE ROOT CAUSE IS A SYSTEM ERROR CAUSED BY A SEGMENTATION FAULT. THIS IS RELATED TO FIRMWARE RESIDENT ON A CPLD. THIS ROOT CAUSE WAS DETERMINED BY EXAMINATION OF THE SERVICE LOG. THE DEVICE FUNCTIONED AS DESIGNED TO INTERRUPT NITRIC OXIDE DELIVERY AND ALARM WHEN SUCH AN ERROR IS DETECTED. THE MAIN CIRCUIT BOARD WAS REPLACED AND THE DEVICE FUNCTIONED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A RESPIRATORY THERAPIST REPORTS THE INOMAX DS, #(B)(4) WENT INTO SYSTEM FAILURE. THE DEVICE WAS NOT ON A PATIENT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. 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