BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ FLOW DIRECT OXIMETRY/THERMODILUTION CATHETER

    MDR report key: 1030813 · Received April 17, 2008

    Report

    Report Number
    6000002-2008-06576
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE CUSTOMER WAS EXPERIENCING IRRATIC ICO (BOLUS) MEASUREMENTS 2-8LPM ON THE VIGILANCE II MONITOR. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ FLOW DIRECT OXIMETRY/THERMODILUTION CATHETER PACEPORT OXIMETRY TD CATHETER DYG EDWARDS LIFESCIENCES, PR 780HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other