BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART HYPER-HYPOTHERMIA

    MDR report key: 7137701 · Received December 21, 2017

    Report

    Report Number
    7137701
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 12, 2017
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLANKET TEMPERATURE WAS SET AT 33.5 DEGREES CELSIUS AND THE ACTUAL BLANKET TEMPERATURE WAS READING 42. INFANT TEMPERATURE REACHED 32.4. THE PHYSICIAN WAS NOTIFIED. RESPIRATORY THERAPY SWITCHED THE MACHINE AND RESTORED THE SETTINGS. THE OLD MACHINE BLANKET TEMPERATURE WAS NOT FLUCTUATING APPROPRIATELY. INFANT TEMPERATURE NOW STABLE AND APPROPRIATE FOR BLANKET SETTING. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917746 SMART HYPER-HYPOTHERMIA SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR