BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 518449 · Received March 12, 2004

    Report

    Report Number
    MW1031550
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    February 13, 2004
    Report Date
    March 11, 2004
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT INJURED IN A MOTOR VEHICLE ACCIDENT, ADMITTED 2004, AND COOLING SYSTEM APPLIED THE NEXT DAY. MACHINE SENSES THE BODY TEMPERATURE VIA A RECTAL THERMOMETER, GOALS ARE DIALED IN AND THE MACHINE ADJUSTS THE WATER FLOW ACCORDINGLY. PADS CHANGED IN EVENING THIRTEEN DAYS LATER BECAUSE OF LOW WATER PRESSURE ALARM. THREE PADS REAPPLIED FOR APPROX 30% COVERAGE. NO FURTHER ALARMS, AND SKIN WAS INTACT, SLIGHTLY RED AND COOL TO TOUCH AS EXPECTED. THE NEXT MORNING SKIN ASSESSED AND NOTED THAT AREA UNDER PADS ON THIGHS WERE DEEP PURPLE IN COLOR AND REDDENED AROUND EDGES. SPOT ALSO NOTED ON RIGHT SCAPULA. SKIN COOL TO TOUCH. SYSTEM REMOVED, PT TREATED AND NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM COOLING SYSTEM DWJ MEDIVANCE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR