BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANCE CONTINUOUS CARDIAC OUTPUT COMPUTER

    MDR report key: 1051961 · Received May 22, 2008

    Report

    Report Number
    6000002-2008-07305
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, SMOKED. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK