BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI-THERM LITE

    MDR report key: 3201084 · Received May 21, 2013

    Report

    Report Number
    3201084
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CINCINNATI SUB ZERO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLANKET LEAKED WATER ALL OVER THE BED AND PATIENT. BLANKET WAS CHANGED OUT AND THERAPY WAS INTERRUPTED. NO OBIOUS ITEMS NOTED THAT WOULD HAVE CONTRIBUTED TO THE LEAK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYPOTHERMIA THERAPY FOR 72 HOURS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225434 MAXI-THERM LITE SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB ZERO MAXI THERM LITE PEDIATRIC HYPERHYPO THERMIA BLANKET 743001

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY NO.| OTHER