BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 1980873 · Received February 7, 2011

    Report

    Report Number
    2015691-2011-14750
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K803058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT GOING TO BE RETURNED FOR EVALUATION. WITHOUT RETURN OF THE PRODUCT, WE ARE UNABLE TO PERFORM A COMPLETE INVESTIGATION INTO A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMISTOR WAS "DEFECTIVE" AND THE PATIENT'S TEMPERATURE WAS OVERESTIMATED. CARDIAC OUTPUT READINGS WERE UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD THERMODILUATION CATHETER DYG EDWARDS LIFESCIENCES, PR 931HF75 58920991

    Patients

    Seq Age Sex Outcome Treatment
    1