BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI-THERM LITE

    MDR report key: 8619296 · Received May 17, 2019

    Report

    Report Number
    8619296
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 7, 2019
    Report Date
    April 12, 2019
    Manufacturer
    CINCINNATI SUBZERO PRODUCTS, LLC (CSZ MEDICAL)
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BABY REQUIRED TOTAL BODY COOLING FOR HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE). WHEN ATTACHING COOLING BLANKET TO COOLING MACHINE AND STARTING TO RUN THE WATER THROUGH, THE BLANKET STARTED LEAKING. HOSES CLAMPED OFF AND BLANKET DETACHED AND REPLACED WITH NEW BLANKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412144 MAXI-THERM LITE PACK, HOT OR COLD, WATER CIRCULATING ILO CINCINNATI SUBZERO PRODUCTS, LLC (CSZ MEDICAL) 874 748019

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA