BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6

    MDR report key: 611352 · Received May 24, 2005

    Report

    Report Number
    2112667-2005-00020
    Event Type
    Malfunction
    Date Received
    May 24, 2005
    Date of Event
    April 26, 2005
    Manufacturer
    GE HEALTHCARE
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND FOUND TO ALARM "NO OUTPUT", PREVENTING FURTHER USE OF THE DEVICE. THE FRE POWER SUPPLY WAS REPLACED, RESOLVING THE ALARM CONDITON. THE FAILURE RATE OF THE FRE POWER SUPPLY MEETS THE INTENDED FAILURE RATE. UPON FURTHER TESTING, THE OUTPUT WAS FOUND TO BE HIGH TO SPECIFICATION. THE CAUSE OF THE OUTPUT WAS FOUND TO BE HIGH TO SPECIFICATION. THE CAUSE OF THE OUTPUT DEVIATION WAS DETERMINED TO BE DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MANUFACTURING PROCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLMENTED INTO THE MANUFACTURING, REFURBISHING AND SERVICE PROCESSES IN 06/1997.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FELT THE OUTPUT OF THEIR VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 CALIBRATED VAPORIZER CAD GE HEALTHCARE TEC 6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *