BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II CCO-SV02/CEDV MONITOR

    MDR report key: 6092220 · Received November 10, 2016

    Report

    Report Number
    2015691-2016-03333
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 19, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VIGILANCE II MONITOR WAS RECEIVED FOR PRODUCT EVALUATION. THE EXAMINATION FOUND THAT WHEN THE MONITOR WAS TESTED WITH A KNOWN GOOD WORKING OM2 CABLE AND WITH A SIMULATOR, THAT IT PASSED THE 72 HOUR BURN-IN TEST AND IT FUNCTIONED AS INTENDED. HOWEVER, DURING THE EXAMINATION IT WAS FOUND THAT THE NAVIGATION ENCODER (KNOB) WAS NOT WORKING PROPERLY. IT WAS REPLACED TO CORRECT THE ISSUE. THE SAFETY TEST WAS PERFORMED AND THE BURN IN TEST AND THE FINAL ACCEPTANCE TEST UNIT, (FATU), TO VERIFY FUNCTIONALITY OF THE MONITOR. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES. THE REPORTED ISSUE WAS NOT CONFIRMED BY EVALUATION; HOWEVER, THE NAVIGATION KNOB NEEDED TO BE REPLACED. THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT¿S CLINICAL MANIFESTATIONS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE STATED EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT EVALUATION IS IN PROGRESS. UPON RETURN OF THE EVALUATION RESULTS A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIGILANCE II MONITOR DISPLAYED CARDIAC OUTPUT NUMBERS THAT WERE ¿UNSTABLE AND CHANGING RAPIDLY." THIS OCCURRED WHILE MONITORING A PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE INCLUDING PATIENT DEMOGRAPHICS. THERE WAS NO OTHER SUSPECT EQUIPMENT INVOLVED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744600 VIGILANCE II CCO-SV02/CEDV MONITOR CC MONITOR VIG2 DXG EDWARDS LIFESCIENCES VIG2

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLES