BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2161747 · Received April 5, 2011

    Report

    Report Number
    3004531588-2011-00021
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 5, 2011
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRP
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A RESPIRATORY THERAPIST (RT) REPORTED THAT THE INOMAX DS, (B)(4) WOULD NOT CALIBRATE AND WENT INTO DELIVERY FAILURE. ON INVESTIGATION 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. FOLLOWING CABLE REPLACEMENT, THE DEVICE PERFORMED TO SPECIFICATIONS. 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 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) 2011, A RESPIRATORY THERAPIST (RT) REPORTED DELIVERY FAILURE ON POWER-UP OF THE INOMAX DS,(B)(4). THE RT ATTEMPTED TO PERFORM LOW AND HIGH CALIBRATIONS BUT THE DEVICE WOULD NOT CALIBRATE. THE DEVICE WAS NOT ON A PATIENT AND NO ADVERSE EVENT WAS REPORTED. THE RT SPOKE WITH (B)(4) TECHNICAL SERVICES WHO REVIEWED SET-UP. THE DEVICE POWER CYCLED TO STAND-BY THEN ON WITH NO CHANGE IN CONDITION. 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 MRP INO THERAPEUTICS, LLC/IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1