BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1831930 · Received September 8, 2010

    Report

    Report Number
    3004531588-2010-00065
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 8, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    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 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 "SERVICE REQUIRED" ALARM THEN A BLACK SCREEN WITH THE INOMAX DS (B)(4) WITH SUBSEQUENT DEVICE FAILURE WHILE ON A (B)(6) FEMALE WITH PULMONARY HYPERTENSION AND A CARDIAC DEFECT. THE PT'S OXYGEN SATURATION (SPO2) DECREASED TO 60% FOLLOWING THE ALARM SOUNDING. THE PT WAS IMMEDIATELY MANUALLY VENTILATED WITH THE INOBLENDER AND RETURNED TO BASELINE OF SPO2 90% WITHIN 30 SECONDS. THE PT'S OXYGEN SATURATION DECREASE RESOLVED AND THE RESPIRATORY THERAPIST DEEMED THE OXYGEN SATURATION DECREASE RELATED TO THE INTERRUPTION IN INOMAX THERAPY. THE DEVICE WAS REBOOTED AND TREATMENT RESUMED. THE PT WAS EVENTUALLY REMOVED FROM THE DEVICE. THE DEVICE WAS REMOVED FROM SERVICE AND RETUNED TO THE COMPANY FOR INSPECTION.

    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 9 MO Other