BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN-GANZ

    MDR report key: 2061327 · Received April 13, 2011

    Report

    Report Number
    MW5020271
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    EDWARD LIFESCIENCES, LLC.
    Product Code
    DYG
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERMODILUTION CATHETER (TOTAL OF 5 CATHETERS) MALFUNCTIONING. THEY WERE NOT RECORDING THE ACCURATE TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION CATHETER DYG EDWARD LIFESCIENCES, LLC. 58971090

    Patients

    Seq Age Sex Outcome Treatment
    1