BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI-THERM LITE

    MDR report key: 6063378 · Received October 28, 2016

    Report

    Report Number
    6063378
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOTED THE HYPER-HYPOTHERMIA BLANKET TO BE WET. UPON EXAMINATION, DETERMINED THAT THE BLANKETS WERE LEAKING. THERE WAS NO HARM TO EITHER PATIENT AS A RESULT OF THIS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716494 MAXI-THERM LITE SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, LLC 873

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR