BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1841868 · Received September 20, 2010

    Report

    Report Number
    3004531588-2010-00075
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INVESTIGATION OF THE DEVICE IS COMPLETE AND IS AS FOLLOWS: THE DEVICE WAS BEING USED IN AN OFF-LABEL, LONG-TERM APPLICATION WHICH WAS NOT ANTICIPATED. A REVIEW OF THE SERVICE LOGS YIELDED THE ALARM, "SERVICE REQUIRED" RESULTING IN A SYSTEM SHUTDOWN. A SOFTWARE ANOMALY WAS FOUND TO BE THE ROOT CAUSE OF THE INCIDENT. THE SOFTWARE HAS BEEN MODIFIED TO ELIMINATE THE ANOMALY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED A "BLANK SCREEN WITH A YELLOW TRIANGLE THAT SAID SYSTEM FAILURE" WITH THE INOMAX DS, # (B)(4). THE PATIENT WAS ON THE DEVICE FOR 22 DAYS. 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 100003

    Patients

    Seq Age Sex Outcome Treatment
    1