BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2020454 · Received February 8, 2011

    Report

    Report Number
    3004531588-2011-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    July 21, 2010
    Report Date
    February 8, 2011
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THAT INOMAX DS, # (B)(4), MONITORED VALUES WERE FLUCTUATING HIGH AND LOW WHILE IN USE ON A PATIENT. EVALUATION SUMMARY: THE INVESTIGATION OF THE DEVICE WAS COMPLETED, WITH RESULTS AS FOLLOWS: ON POWER UP OF THE DEVICE AT A SERVICE CENTER DURING THE INVESTIGATION IT WAS NOTED THAT THE NITRIC OXIDE (NO) MONITORED VALUES WERE FLUCTUATING. THE ROOT CAUSE OF THE FLUCTUATING NO VALUES WAS IDENTIFIED AS FRETTING CORROSION AT THE CONNECTOR END OF A 20 CONDUCTOR RIBBON CABLE. THE CABLE WAS REPLACED, A FULL SYSTEM CHECK WAS PERFORMED AND THE UNIT OPERATED ACCORDING TO SPECIFICATIONS. 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 THAT INOMAX DS # (B)(4) MONITORED VALUES WERE FLUCTUATING HIGH AND LOW WHILE IN USE ON A PATIENT. THE CUSTOMER CONTACTED (B)(6)TECHNICAL SUPPORT, BUT REFUSED TO TROUBLESHOOT THE DEVICE. THE DEVICE WAS SWITCHED OUT AND NO ADVERSE EVENT WAS REPORTED. 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