BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI-THERM LITE

    MDR report key: 966566 · Received December 12, 2007

    Report

    Report Number
    966566
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    October 9, 2007
    Report Date
    November 25, 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

    WHILE INFANT WAS ON BODY COOLING, THE BLANKET BEGAN TO LEAK LARGE AMOUNTS OF WATER. THERE WAS AN APPARENT HOLE/LACERATION IN THE BLANKET ITSELF. THE BLANKET IN USE WHEN LEAK OCCURRED WAS MAXI-THERM LITE, CATALOG NUMBER 874 BY CINCINNATI SUB-ZERO. THE BLANKET AND THE BED WERE IMMEDIATELY REPLACED, INFANT TEMPERATURE REMAINED AT RECOMMENDED LEVEL (32.5 C) FOR TREATMENT AFTER CHANGE OUT OF EQUIPMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI-THERM LITE PAD, HYPO/HYPERTHERMIA DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. NA 8288

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA