BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE II CONTINUOUS CARDIAC OUTPUT COMPUTER

    MDR report key: 1673344 · Received May 4, 2010

    Report

    Report Number
    2015691-2010-13269
    Event Type
    Malfunction
    Date Received
    May 4, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRT
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, CUSTOMER DOES NOT BELIEVE SVO2 VALUE. QUESTIONING IF THERE IS A DISCREPANCY BETWEEN INVITRO VS. INVIVO AND ACTUAL VENOUS BLOOD GAS DRAW. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1