BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1881288 · Received October 6, 2010

    Report

    Report Number
    3004531588-2010-00084
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 6, 2010
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED FLUCTUATING NITRIC OXIDE (NO) VALUES WITH THE INOMAX DS, (B)(4). EVAL SUMMARY: THE ROOT CAUSE OF THE DELIVERY FAILURE INVOLVES FRETTING CORROSION OF CONDUCTING TRACES IN AN INTERNAL RIBBON CABLE. THE FRETTING CORROSION CAN CAUSE INTERMITTENT HIGH RESISTANCE CONNECTION TO THE CABLE'S CONNECTOR, CAUSING FLUCTUATING MONITORED (NO) READINGS. THE INTERNAL RIBBON CABLE WAS REPLACED AND IT WAS CONFIRMED THE MONITORED FLUCTUATING MONITORED NO READINGS STOPPED AND WERE CORRECTED. IT IS IMPORTANT TO NOTE THAT THE MONITORED NO LEVEL 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 FLUCTUATING NITRIC OXIDE (NO) VALUES WITH THE INOMAX DS, (B)(4). THE RESPIRATORY THERAPIST STATES THERE WAS NO HARM TO PT AND NO ADVERSE EVENT OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER UNIT. 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