BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6 PLUS

    MDR report key: 1024154 · Received March 24, 2008

    Report

    Report Number
    2112667-2008-00013
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 2, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CAD
    PMA / PMN Number
    K000275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS NOT ACCURATE. THERE WAS NO REPORT OF PT INVOLVEMENT. INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED. ONCE THE ROTARY VALVE AND VALVE PLATE WERE REPLACED, THE UNIT FUNCTIONED WITHIN MANUFACTURE'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 PLUS CALIBRATED VAPORIZER CAD DATEX-OHMEDA 1107960100

    Patients

    Seq Age Sex Outcome Treatment
    1