BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1881815 · Received October 8, 2010

    Report

    Report Number
    3004531588-2010-00087
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THE NITRIC OXIDE (NO) ANALYZER (MONITOR) ON THE INOMAX DS # (B)(4) WAS READING BETWEEN 5 AND 40 PARTS PER MILLION WHILE RUNNING WITH AN OSCILLATOR. EVALUATION SUMMARY PAGE - ON INVESTIGATION, WE WERE UNABLE TO DUPLICATE THE REPORTED CONDITION WITH THIS DEVICE. HOWEVER, ON EXAMINATION OF THE DEVICE SERVICE LOG, FLUCTUATING MONITORED NITRIC OXIDE (NO) VALUES WERE RECORDED. SINCE FLUCTUATING MONITORED NO VALUES HAVE BEEN OBSERVED IN THE SERVICE LOGS OF OTHER DEVICES AND HAVE BEEN LINKED TO FRETTING CORROSION OF AN INTERNAL RIBBON CABLE, THE CABLE WAS REPLACED. THE FRETTING CORROSION CAN LEAD TO INTERMITTENT HIGH RESISTANCE CONNECTION AT THE CABLE'S CONNECTOR, LEADING TO FLUCTUATING MONITORED NO VALUES. IT IS IMPORTANT TO NOTE THAT THE MONITORED NO VALUE WOULD BE FLUCTUATING IN THIS CASE AND NOT THE ACTUAL NO DELIVERED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THE NITRIC OXIDE (NO) ANALYZER (MONITOR) ON THE INOMAX DS # (B)(4) WAS READING BETWEEN 5 AND 40 PARTS PER MILLION WHILE RUNNING WITH AN OSCILLATOR. THE RESPIRATORY THERAPIST STATES THERE WAS NO HARM TO PATIENT AND NO ADVERSE EVENT OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND IS SCHEDULED TO BE 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