BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1841887 · Received September 20, 2010

    Report

    Report Number
    3004531588-2010-00076
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 (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 FLUCTUATION IN THE NITRIC OXIDE (NO) READING FROM -6 TO -35 PARTS PER MILLION (PPM) ON INOMAX DS, #(B)(4) WHILE SET AT 30PPM. 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 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