BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI-THERM LITE COOLING BLANKET

    MDR report key: 833722 · Received March 8, 2007

    Report

    Report Number
    833722
    Event Type
    Malfunction
    Date Received
    March 8, 2007
    Date of Event
    January 22, 2007
    Report Date
    March 8, 2007
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S DAD CAME OUT AND REPORTED THE BLANKET WAS LEAKING AND THE BED WAS WET. NURSE WAS CALLED TO THE BEDSIDE AND FOUND THE LINENS WERE WET. THE UPPER AND LOWER BLANKET WERE REMOVED AND NEW BLANKETS WERE OBTAINED. AFTER THE EVENT, STAFF CONTINUED TO WARM THE PATIENT. PATIENT'S TEMPERATURE DECREASED APPROXIMATELY 0.1 DEGREE CELSIUS. THIS FAILURE POSES SEVERAL POTENTIALLY SERIOUS INJURIES: 1. WATER COULD REACH ELECTRICAL EQUIPMENT AND CAUSE AN ELECTRIC SHOCK. 2. IF PARENTS HAD NOT BEEN AT THE BEDSIDE, PATIENT MAY HAVE BECOME HYPOTHERMIC VERY QUICKLY BY LYING IN COLD WATER. 3. ANYONE COMING INTO ROOM IS AT RISK OF FALLING DUE TO THE WATER ON THE FLOOR. MANUFACTURER'S RESPONSE WAS THAT THESE BLANKETS AND ALL BLANKETS MANUFACTURED AFTER THEM HAVE UNDERGONE A NEW MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI-THERM LITE COOLING BLANKET BLANKET, COOLING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. * 7796

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO