BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1800120 · Received August 10, 2010

    Report

    Report Number
    3004531588-2010-00028
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 10, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPIRATORY THERAPIST REPORTED INOMAX DS DEVICE # (B)(4) HAD BOUNCING NITRIC OXIDE (NO) LEVELS. EVAL SUMMARY: ALTHOUGH, THE WIDELY VARYING NITRIC OXIDE VALUES WERE NOT REPRODUCIBLE DURING THE DEVICE INVESTIGATION, THE DEVICE SERVICE LOGS SUGGEST THE ROOT CAUSE FOR THIS ISSUE COULD BE 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. 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 INOMAX DS DEVICE # (B)(4) HAD BOUNCING NITRIC OXIDE (NO) LEVELS. THE RESPIRATORY THERAPIST STATES, THERE WAS NO HARM TO PT AND NO ADVERSE EVENT OCCURRED. THE DEVICE WAS SUBSEQUENTLY REPLACED WITH ANOTHER UNIT.

    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