BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCE LLC

    MDR report key: 623742 · Received July 15, 2005

    Report

    Report Number
    623742
    Event Type
    Malfunction
    Date Received
    July 15, 2005
    Date of Event
    June 23, 2005
    Report Date
    July 14, 2005
    Manufacturer
    EDWARDS LIFESCIENCE LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SWAN GANZ CATH WOULD NOT READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCE LLC SWAN GANZ CATHETER DYG EDWARDS LIFESCIENCE LLC NI 235CC342

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other