BEUDAMED
    FDA Adverse Event Summary report: N

    GAYMAR

    MDR report key: 1183132 · Received September 16, 2008

    Report

    Report Number
    1183132
    Date Received
    September 16, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    STAFF WAS USING A GAYMAR HYPO/HYPERTHERMIA MACHINE FOR THERAPEUTIC HYPOTHERMIA PROTOCOL POST CARDIAC ARREST. TEMPERATURE WAS 36*C AFTER INITIATION/COMPLETION OF PROTOCOL. PATIENT'S POSTERIOR TRUNK WAS NOTED TO HAVE RASH LIKE CHANGES. SKIN BECAME MORE REDDENED AND BLISTERED IN THE PATTERN OF THE HYPOTHERMIA PAD. REDNESS DIAGNOSED AS A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR HYPO/HYPERTHERMIA MACHINE DWJ GAYMAR INDUSTRIES, INC. MTA6900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR