BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II CCO-SV02/CEDV MONITOR

    MDR report key: 6108964 · Received November 17, 2016

    Report

    Report Number
    2015691-2016-03395
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT BEEN RECEIVED YET. UPON RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE EVALUATION FINDINGS. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT VIGILANCE II MONITOR WAS NOT RETURNED BY THE FACILITY FOR PRODUCT EVALUATION. EDWARDS IS UNABLE TO CONFIRM OR NEGATE THE CUSTOMERS EXPERIENCE WITHOUT THE RETURN OF THE SUSPECT DEVICE. IF THE PRODUCT IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE SERVICE HISTORY RECORD REPORT WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES. WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT¿S CLINICAL MANIFESTATIONS. 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 A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    ONE VIGILANCE2 MONITOR WAS RECEIVED FOR PRODUCT EVALUATION FOR ANALYSIS AND TESTING. THE BURN-IN TEST WAS PERFORMED DURING A 36 HOUR PERIOD AND THE SUSPECT MONITOR PASSED THE TEST WITHOUT ANY ISSUES NOTED. THE CONTINUOUS CARDIAC OUTPUT (CCO) READINGS THAT WERE DISPLAYED WERE WITHIN ACCEPTABLE LIMITS. THE SATURATION VENUS OUTPUT (SVO) READINGS DISPLAYED WERE WITHIN ACCEPTABLE LIMITS. THE FINAL ACCEPTANCE TEST UNIT (FATU), WAS PERFORMED AND THE MONITOR PASSED THE TEST. THERE WAS NO DEFECT IDENTIFIED. THE DEVICE SERVICE HISTORY RECORD REPORT WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES. 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 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 A PART OF THE MONTHLY REVIEW. THE REPORTED EVENT WAS NOT CONFIRMED BY EVALUATION. THERE IS NO EVIDENCE OR INDICATION THAT A MANUFACTURING DEFECT IS RESPONSIBLE FOR THE REPORTED ISSUE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A PATIENT WAS BEING MONITORED WITH A SWAN GANZ CATHETER AND A VIGILANCE II MONITOR, THE CCO VALUES WERE NOTED TO BE FROM 8.8-10.9, WHICH IS NOT WHAT THE CLINICIAN ANTICIPATED GIVEN THE PATIENT STATUS. THE CLINICIAN SWAPPED OUT THE MONITOR AND THE ISSUE WAS RESOLVED. THERE WAS NO OTHER SUSPECT EQUIPMENT INVOLVED. THERE WERE NO ERROR MESSAGES OBSERVED. FURTHER INFORMATION, INCLUDING PATIENT DEMOGRAPHICS, WAS NOT ABLE TO BE OBTAINED. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760628 VIGILANCE II CCO-SV02/CEDV MONITOR CC MONITOR VIG2 DXG EDWARDS LIFESCIENCES VIG2

    Patients

    Seq Age Sex Outcome Treatment
    1 SWAN GANZ CATHETER