BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II MONITOR

    MDR report key: 2228248 · Received May 23, 2007

    Report

    Report Number
    6000002-2007-00377
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    January 5, 2007
    Report Date
    January 5, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4): INCORRECT PARAMETER CALCULATIONS. EDWARDS LIFESCIENCES TECHNICAL SUPPORT VISITED ACCOUNT ON (B)(4) 2007 TO TROUBLESHOOT AND UNDERSTAND ROOT CAUSE. IN ADDITION, GE SALES REP VISITED ACCOUNT AS WELL TO TROUBLESHOOT. FURTHER INVESTIGATION IS BEING CONDUCTED AT THIS TIME. THE DFU INSTRUCTS THE USER TO VERIFY THE SLAVED MAP VALUES WITH THOSE DISPLAYED ON THE BEDSIDE MONITOR. REFERENCE VIGILANCE II DFU, SECTION 2-6. THE STATEMENT IS AS FOLLOWS: "CAUTION: THE ACCURACY OF CONTINUOUS SVR, VQI AND O2 EL DEPENDS UPON THE QUALITY AND ACCURACY OF THE MAP, CVP AND SA02 DATA TRANSMITTED FROM THE EXTERNAL MONITORS. SINCE MAP, CVP, AND SA02 ANALOG SIGNAL QUALITY FROM THE EXTERNAL MONITOR CANNOT BE VALIDATED BY THE VIGILANCE II MONITOR, ACTUAL VALUES AND THE VALUES (INCLUDING ALL DERIVED PARAMETERS) DISPLAYED BY THE VIGILANCE II MONITOR MAY NOT BE CONSISTENT. THE ACCURACY OF CONTINUOUS SVR, VQI AND O2EL MEASUREMENT, THEREFORE, CANNOT BE GUARANTEED. TO AID IN DETERMINING THE QUALITY OF THE ANALOG SIGNALS, REGULARLY COMPARE THE MAP, CVP AND SA02 VALUES DISPLAYED ON THE EXTERNAL MONITOR TO THE VALUES DISPLAYED ON THE VIGILANCE MONITOR. REFER TO EXTERNAL INPUT DEVICE OPERATOR'S MANUAL FOR DETAILED INFORMATION REGARDING ACCURACY, CALIBRATION, AND OTHER VARIABLES WHICH MAY IMPACT THE ANALOG OUTPUT SIGNAL FROM THE EXTERNAL MONITOR. DEVICE WAS NOT RETURNED AND THEREFORE WAS UNABLE TO EVALUATE. DEVICE 2: BRAND NAME: PRESSURE SLAVE CABLE; TYPE OF DEVICE: ANALOGUE SLAVE CABLE; MANUFACTURER: EDWARDS LIFESCIENCES, (B)(4); MODEL#: 70ANM5, OTHER#: 2006-12; SINGLE USE DEVICE THAT WAS REPROCESSED?: NO; DEVICE AVAILABLE FOR EVALUATION?: NO; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAP (MEAN ARTERIAL PRESSURE) VALUE SLAVED FROM THE GE SOLAR 8000M SYSTEMS (BEDSIDE MONITOR) TO THE VIGILANCE II DISPLAYED AS MUCH AS A 20 MMHG DISCREPANCY. NO PATIENT COMPLICATIONS WERE REPORTED. ACCOUNT WAS A NEW USER TO THE SYSTEM AS OF (B)(4) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILANCE II MONITOR CONTINUOUS CARDIAC OUTPUT COMPUTER DXG EDWARDS LIFESCIENCES VIG2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other