BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CZS CINCINNATI SUB-ZERO MODEL 135 WARMAIR DEVICE

    MDR report key: 1353775 · Received March 30, 2009

    Report

    Report Number
    MW5010547
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    March 24, 2009
    Report Date
    March 30, 2009
    Manufacturer
    CZS PRODUCTS INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BURNING ODOR SMELLED DURING SURGICAL PROCEDURE. SURGERY WAS PAUSED TO INVESTIGATE ODOR. STERILITY WAS MAINTAINED, WHILE SURGICAL FIELD AND UNDER DRAPES WERE INVESTIGATED. A FORCED AIR WARMER WAS REMOVED. PATIENT WAS CLOSELY OBSERVED DURING PROCEDURE, AND EXAMINED BY SURGICAL TEAM POST-PROCEDURE. NO HARM TO PATIENT OBSERVED. WARMING BLANKET NOTED TO BE DISCOLORED AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CZS CINCINNATI SUB-ZERO MODEL 135 WARMAIR DEVICE WAMING BLANKET & MODULE DWJ CZS PRODUCTS INC. 135 WARMER

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability