BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGIELO APCO/OXIMETRY MONITOR

    MDR report key: 4998650 · Received August 12, 2015

    Report

    Report Number
    2015691-2015-02033
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K062134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS THE SECOND MONITOR OF TWO MONITORS INVOLVED IN THE REPORTED EVENT - AT THE TIME OF THIS SUBMISSION, THE SERIAL NUMBERS FOR EACH MONITOR IS UNKNOWN. ADDITIONAL INFORMATION IS FORTHCOMING. BOTH MONITORS WILL BE REQUESTED FOR RETURN AND THE EVALUATION OF THE SUSPECT DEVICE(S) IS ANTICIPATED. A FOLLOW-UP SUBMISSION WILL COMMUNICATE THE SERIAL NUMBER, RESULT OF THE DEVICE HISTORY REVIEW, THE RETURNED PRODUCT EVALUATION RESULT(S), INVESTIGATION AND CONCLUSION. PLEASE REFER TO MANUFACTURER¿S REPORT NUMBERS 2015691-2015-02020 WITH REFERENCE TO THE SUSPECT FLOTRAC SENSOR, AND 2014591-2015-02022 WITH REFERENCE TO THE OTHER VIGILEO MONITOR REPORTED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THE DEVICE IDENTIFIED IN COMPLAINT (B)(4) WHICH CORRELATES TO THIS REPORT, IS (B)(4). THE MONITOR WAS MANUFACTURED MARCH 22, 2010 AND REVIEW OF THE DEVICE HISTORY RECORD SUPPORTS THAT THERE WERE NO NON-CONFORMANCES NOTED FOR ANY REASON. PER EDWARDS¿ PROCEDURE, THE USEFUL LIFE OF THE MONITOR IS 5 YEARS. THE REFERENCED MONITOR HAS EXCEEDED ITS ESTABLISHED USEFUL LIFE. EVALUATION OF THE RETURNED MONITOR WAS UNABLE TO REPLICATE THE VALUES REPORTED BY THE CUSTOMER. OVER 36 HOURS OF TESTING WAS PERFORMED, WITH NO PERFORMANCE ISSUES NOTED FOR ANY REASON. HOWEVER, DURING EXAMINATION OF THE MONITOR, IT WAS NOTICED THAT A RUBBER FOOT WAS MISSING; THE FOOT WAS REPLACED. THE FOREGOING ISSUE WAS NOT ASSOCIATED TO THE CUSTOMER¿S EXPERIENCE REGARDING THE CI VALUE. AN ADDITIONAL MONITOR REFERENCED IN THE COMPLAINT, (B)(4), SERIAL NUMBER (B)(4) WAS ALSO EXEMPTED AS CONTRIBUTOR TO THE CUSTOMER'S REPORT. THE EVALUATION RESULTS FOR THE SECOND MONITOR CONCLUDED THAT THE MONITOR FUNCTIONED AS EXPECTED (SEE MDR 2015691-02022). COMPLAINTS (B)(4) WERE INITIATED FOR THE ASSOCIATED FLOTRAC SENSORS; HOWEVER, THE SENSORS WERE NOT RECEIVED FOR EVALUATION. WITHOUT RETURN OF THE FLOTRAC SENSORS, WE ARE UNABLE TO PERFORM A COMPLETE INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. IF ACTION IS REQUIRED, AN APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCORRECT CI VALUE WAS SHOWN ON THE VIGILEO MONITOR DURING USE. AROUND 0.7 TO 1.5L WAS SHOWN, ALTHOUGH THE CUSTOMER WAS EXPECTING VALUES OVER 2.0L. THERE WAS NO PROBLEM ZEROING BEFORE USE. THERE WAS ALSO NO PROBLEM NOTED ON THE SHAPE OF THE PRESSURE WAVEFORM AND THE PRESSURE VALUE AND THE WAVEFORM MATCHED. FLOTRAC UNIT AND MONITOR WAS EXCHANGED BUT THE PROBLEM WAS NOT SOLVED. ERROR MESSAGES WERE NOT THERE WERE NO OCCLUSION, LEAKAGE, NOR KINKS OBSERVED. VIGILEO DATA WAS OBTAINED (SEE ATTACHED).THE PATIENT WAS NOT TREATED BASED ON THE INACCURATE VALUES, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE EDWARDS SALES REPRESENTATIVE. INITIALLY, THERE WAS NO COMPLAINT FOR THE MONITORS REPORTED FROM THE SALES REP., THE REPORTED COMPLAINT WAS ONLY FOR FLOTRAC. HOWEVER, FOLLOW-UP WITH THE SALES REP. CONFIRMED THAT THE VIGILEO MONITORS WERE ALSO CONSIDERED SUSPECT. TWO ADDITIONAL COMPLAINTS (-2 & -3) WERE INITIATED TO ADDRESS THE SUSPECT VIGILEO MONITORS: INITIAL MONITOR AND 'CHANGED' MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528243 VIGIELO APCO/OXIMETRY MONITOR SINGLE-FUNCTION, PREPROGRAMMED DIAGNOSTIC COMPUTER DXG EDWARDS LIFESCIENCES MHM1

    Patients

    Seq Age Sex Outcome Treatment
    1