BEUDAMED
    FDA Adverse Event Summary report: N

    ARCTIC SUN

    MDR report key: 3982978 · Received July 21, 2014

    Report

    Report Number
    3982978
    Date Received
    July 21, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDIVANCE, INC
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEPTIC, HTN, SAH, FEVER; FRAGILE SKIN FROM ILLNESS. MANUFACTURER RESPONSE FOR MEDIVANCE ARCTIC SUN TEMPERATURE MGMT SYSTEM, ARTIC SUN (PER SITE REPORTER)======================WILL RUN DIAGNOSTICS TESTING; CAN HAPPEN WHEN NOT CHANGED EVERY 5 DAYS AS IT IS A WATER BASE PRODUCT THAT ATTACHES TO PATIENTS. NEED MONITORING AS PATIENTS SKIN CHANGES.UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED, WE HAVE TWO UNITS, BOTH WILL BE TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426683 ARCTIC SUN SYSTEM, THERMAL REGULATING DWJ MEDIVANCE, INC 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR LONG-TERM ANTIBIOTICS