BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1162283 · Received September 5, 2008

    Report

    Report Number
    6000002-2008-08614
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    EDWARDS LIFESCINECES
    Product Code
    DYG
    PMA / PMN Number
    K924452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON HAD A DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCINECES 744HF75 58533455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other