BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN

    MDR report key: 2192392 · Received July 2, 2011

    Report

    Report Number
    2192392
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 18, 2011
    Report Date
    July 2, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE ICU NURSE WAS CHECKING THE PATIENT'S TEMPERATURE. THE READINGS WERE OFF. NO EXACT INFORMATION AVAILABLE EXCEPT THE PA READING WAS HIGHER THAN THE TEMPANIC, TEMPORAL, AND ORAL READING BY A FEW DEGREES (2 OR 3). THE ICU NURSE CHANGED OUT ALL MODULES AND CABLES WITH NO APPARENT CHANGES. BIOMED WAS THEN CALLED IN TO EXAMINE THE MONITOR AND ALL CABLES. THEY FOUND NO APPARENT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN CATHETER, FLOW DIRECTED, SWAN GANZ DYG EDWARDS LIFESCIENCES, LLC. 831HF75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.