BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORM-O-TEMP / MAXI-THERM LITE BLANKET

    MDR report key: 3952965 · Received June 19, 2014

    Report

    Report Number
    1516825-2014-00001
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K120081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NORM-O-TEMP SYSTEM IS COMPOSED OF A HEATER, CIRCULATING PUMP, AND BLANKETS/PADS. IT IS INTENDED FOR USE BY APPROPRIATELY TRAINED HEALTHCARE PROFESSIONALS IN CLINICAL ENVIRONMENTS. THE MAXI-THERM LITE BLANKET IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    PT DEVELOPED TISSUE INJURY ALLEGED TO BE 2ND DEGREE BURNS AS A RESULT OF AN EIGHT HOUR SURGICAL ABDOMINAL AORTIC ANEURYSM (AAA) STENTING PROCEDURE WHERE THE PT WAS IMMOBILE IN A SUPINE POSITION WITH LEGS IN THE "FROGGED" POSITION (NO PT ROTATION). DAMAGE OCCURRED AT FOUR CONTACT POINTS [POSTERIOR LATERAL KNEE (BOTH L&R) AND POSTERIOR LATERAL HEEL (BOTH L&R)]. THE CSZ MAXI-THERM LITE BLANKET WAS UNDER A SHEET AND ON TOP OF GEL ROLLS THAT WERE UNDER THE KNEES OF THE PT. SILVADENE TOPICAL CREAM PRESCRIBED TO PT - NO SURGICAL INTERVENTION REQUIRED. THE CSZ NORM-O-TEMP UNIT TEMPERATURE WAS SET AT 42C FOR THE DURATION OF THE EIGHT HOUR PROCEDURE. ASSOCIATED CSZ DEVICES: CSZ NORM-O-TEMP MODEL 111W (115V) USED IN CONJUNCTION WITH A MAXI-THERM LITE BLANKET MODEL 876. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360071 NORM-O-TEMP / MAXI-THERM LITE BLANKET SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 111W - P/N 86157

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention