BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN GANZ CATHETER

    MDR report key: 33100 · Received May 22, 1996

    Report

    Report Number
    MW1009136
    Event Type
    Other
    Date Received
    May 22, 1996
    Date of Event
    March 4, 1996
    Report Date
    May 20, 1996
    Manufacturer
    EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER PLACED - UNABLE TO OBTAIN CORE TEMPERATURE. UPON EXAMINATION, 1 OF 4 WIRES FOUND MISSING FROM THERMISTOR PORT. CATHETER REMOVED. NEW CATHETER OBTAINED AND PLACED. PACKAGING DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ CATHETER THERMODILUTION CATHETER DYG EDWARDS CVS DIV. BAXTER HEALTHCARE CORP. 93A-831H-75F

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other