BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1040669 · Received May 7, 2008

    Report

    Report Number
    6000002-2008-07061
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    January 30, 2008
    Report Date
    April 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC INDEX WAS 3. 5 TO 4.2 ALL NIGHT LONG. AT 07:45 CARDIAC INDEX INCREASED TO 7.2 WHEN NO INTERVENTION HAD BEEN DONE. ALL OTHER VITAL SIGNS WERE NORMAL. A MANUAL CARDIAC INDEX WAS 3.2 AND THE CONTINUOUS CARDIAC INDEX HAD DROPPED TO 5.1. THE MONITOR WAS TURNED OFF AND THEN BACK ON AGAIN. 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 58443791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other