BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ, VIP

    MDR report key: 2020655 · Received March 7, 2011

    Report

    Report Number
    2020655
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    I SPOKE WITH THE NURSE IN THE ICU WHO HAD THE SWAN-GANZ CATHETER. SHE STATED, WHEN THE PATIENT FIRST ARRIVED AND WAS HOOKED UP TO THE PHYSIOLOGICAL MONITORS, THE TEMPERATURE WOULD REGISTER NORMAL THERMAL 98 DEGREES. AFTER AWHILE IT WOULD SLOWLY CREEP UP UNTIL IT REGISTERED 104 DEGREES. SHE SAID THAT THEY TOOK THE TYMPANIC TEMPERATURE, TEMPLE, AND ORALLY AND THEY WERE NORMAL THERMAL. SHE EVEN CHECKED THE PATIENT TO MAKE SURE THEY DID NOT FEEL WARM. SHE SAID THEY CHANGED THE CABLES, MODULE AND USED A DIFFERENT MONITOR. NONE OF THESE CHANGES MADE A DIFFERENCE. MANUFACTURER RESPONSE FOR CATHETER, FLOW DIRECTED, SWAN-GANZ, VIP: SENDING BOX IN TO RETURN AND SENDING A REPLACEMENT. WILL ALSO SEND REPORT AFTER EXAMINATION OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ, VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES 831HF75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR