BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVANCE ARCTIC SUN

    MDR report key: 3072562 · Received April 16, 2013

    Report

    Report Number
    3072562
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    December 28, 2012
    Report Date
    April 16, 2013
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ARCTIC SUN STARTED AT 1800; PATIENT WARMED TOO QUICKLY. LIKELIHOOD OF PHYSIOLOGIC REWARMING DUE TO PATHOPHYSIOLOGY WAS REMOTE DUE TO EXTREME HYPOTHERMIA PRE-ARCTIC SUN. NO PATIENT HARM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163813 MEDIVANCE ARCTIC SUN SYSTEM, THERMAL REGULATING DWJ MEDIVANCE, INC. 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR