BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWN-GANZ & EDSLAB HEPARIN COATED CATHETERS

    MDR report key: 1184429 · Received September 24, 2008

    Report

    Report Number
    6000002-2008-08754
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    EDWARDS LIFESCINECES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPERATURE MEASUREMENT VARIED AND IT WAS UNABLE TO MEASURE CARDIAC OUTPUT VALUES. FOLLOW UP INDICATED THAT THE BLOOD TEMPERATURE MEASUREMENT VALUE WAS VARIED AND UNSTABLE AND IT WAS UNABLE TO MEASURE CARDIAC OUTPUT VALUES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWN-GANZ & EDSLAB HEPARIN COATED CATHETERS THERMODILUTION CATHETER WITH AMC THROMBOSHIELD DYG EDWARDS LIFESCINECES, PR TS258H5F 58537587

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other