BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II CONTINUOUS CARDIAC OUTPUT COMPUTER

    MDR report key: 1232105 · Received November 3, 2008

    Report

    Report Number
    6000002-2008-09153
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 5, 2008
    Manufacturer
    EDWARDS LIFESCINECES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, IF USED WITH EDWARDS IN-LINE PROBE VIGILANCE II MONITOR CALCULATES VERY LOW CO VALUES IF THE CO IS LOW (CO ~ 1.4 - 2.0). IF CO IS HIGH THERE IS A VARIANCE OF BOLUS VALUES OF OVER 50%. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILANCE II CONTINUOUS CARDIAC OUTPUT COMPUTER CONTNUOUS CARDIAC OUTPUT COMPUTER DXG EDWARDS LIFESCINECES VIG2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK