BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1112052 · Received August 4, 2008

    Report

    Report Number
    6000002-2008-08330
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 18, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONTINUOUS CARDIAC OUTPUT WAS TOO LOW TO SUSTAIN LIFE (0.9 INDEX: 2.0 CCO). NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other