BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SWAN-GANZ COO

    MDR report key: 4264241 · Received November 5, 2014

    Report

    Report Number
    4264241
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 29, 2014
    Report Date
    November 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES,LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE SWAN-GANZ CCO BALLOON WOULD NOT STAY INFLATED WHEN SYRINGE PUSHED. TRADED OUT FOR 2ND SWAN-GANZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709364 EDWARDS SWAN-GANZ COO CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES,LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR