BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN

    MDR report key: 1031610 · Received April 17, 2008

    Report

    Report Number
    MW5006298
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MEDIVANCE COMPANY
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON THE ARCTIC SUN HYPOTHERMIA MANAGEMENT SYSTEM, AN OUTLINE OF THE VEST WRAP ON THE PT'S TRUNK, AND THE THIGHS FROM THE ARCTIC GEL PADS CAN BE NOTED. IT APPEARS LIKE THE SKIN IS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM DWJ MEDIVANCE COMPANY 2000-02 A6B2701

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCTIC SUN GEL PADS