BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCTIC SUN 5000

    MDR report key: 2209546 · Received August 8, 2011

    Report

    Report Number
    MW5021695
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDIVANCE
    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

    ARCTIC SUN WAS PLACED ON PATIENT FOR RE-WARMING. ARCTIC SUN WAS PROGRAMMED CORRECTLY, ARCTIC SUN REP CALLED (B)(6) AND MICU RN WAS AT BEDSIDE WITH ARCTIC SUN REP PUTTING IT IN MANUAL MODE. AFTER TEN MINUTES, ARCTIC SUN REP CALLED BACK TO SEE IF MACHINE WAS WORKING, HOWEVER, IT WAS NOT RE-WARMING THE PATIENT. ARCTIC SUN REP SAID THE MACHINE WAS NOT WORKING PROPERLY AFTER A SERIES OF TESTS DONE BY MICU RN ON THE ARCTIC SUN MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN 5000 THERAPEUTIC HYPOTHERMIC DEVICE DWJ MEDIVANCE 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other