BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM-AIR

    MDR report key: 1403501 · Received May 4, 2009

    Report

    Report Number
    1516825-2009-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2009
    Date of Event
    March 24, 2009
    Report Date
    May 1, 2009
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K942599
    Removal / Correction Number
    1516825-2/16/2009-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): MODEL # 135 WARMER. CATALOG #: 09001 LOWER BODY BLA. ALSO REPORTED TO MANUFACTURER.

    Description of Event or Problem · 1

    A WARM-AIR DEVICE WAS REPORTED TO HAVE MALFUNCTIONED DURING A SURGICAL PROCEDURE ON (B)(6)2009. THE UNIT AND BLANKET INVOLVED WERE RETURNED TO CSZ ON (B)(6)2009. SUBSEQUENT EVALUATION HAS CONFIRMED THAT THE UNIT EXHIBITS THE SAME FAILURE AS THOSE INVOLVED IN A RECALL INITIATED ON 2/16/09. OUR RECORDS INDICATE THAT THE USER FACILITY WAS PROVIDED THE CUSTOMER RECALL LETTER AT THAT TIME. THE LETTER INSTRUCTS TO INSPECT ALL UNITS. THE USER FACILITY REPORTS THAT THERE WAS NO HARM TO THE PATIENT. HOWEVER, THIS REPORT SUBMISSION IS TO RESPOND TO THE DEVICE MALFUNCTION. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: 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 WARM-AIR PATIENT WARMER DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 135

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention FILTER FLO UPPER BODY BLANKET