BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6

    MDR report key: 559484 · Received May 7, 2004

    Report

    Report Number
    2112667-2004-00041
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    March 26, 2004
    Report Date
    May 4, 2004
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FELT THE OUTPUT OF THEIR VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PT INJURY. THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES WERE IMPLEMENTED INTO THE MANUFACTURING, REFURBISHING AND SERVICE PROCESSES IN 06/1997. IT SHOULD BE NOTED THAT, ACCORDING TO DATEX OHMEDA RECORDS, THIS UNIT HAS NOT BEEN SERVICED SINCE 1999. DATEX-OHMEDA RECOMMENDS THE TEC 6 VAPORIZER BE SERVICED EVERY 2 YEARS, AS STATED IN THE TEC 6 OPERATION AND MAINTENANCE MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 CALIBRATED VAPORIZER CAD DATEX-OHMEDA, INC. TEC 6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN