BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIGILANCE CONTINUOUS CARDIAC OUTPUT COMPUTER

    MDR report key: 408790 · Received August 2, 2002

    Report

    Report Number
    6000002-2002-00311
    Event Type
    Other
    Date Received
    August 2, 2002
    Date of Event
    June 27, 2002
    Report Date
    July 3, 2002
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING USE, MONITOR DISPLAYED A CARDIAC INDEX OF 1.6, WHICH WAS LOW. NO ERROR MESSAGE ON MONITOR. USER WAITED APPROX 10 MINUTES FOR NUMBER TO CHANGE, BUT NO CHANGES OBSERVED. HOSPITAL GAVE PT 500CC SALINE AND DOUBLED THEIR DOSE OF DOPAMINE. AFTER 20 MINUTES, NO CHANGE IN "CCI", BUT CHANGE OBSERVED IN BLOOD PRESSURE MEASUREMENT. NOT KNOWN IF BOLUS SHOT. USER CHANGED MONITOR AND CARDIAC INDEX WENT TO 5.8. NO PT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention