BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 5100055 · Received September 24, 2015

    Report

    Report Number
    5100055
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    May 18, 2015
    Report Date
    September 18, 2015
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO CALIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630596 SWAN-GANZ SWAN GANZ CATHETER DYG EDWARDS LIFESCIENCES, LLC. 59967285

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR