BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEC 6

    MDR report key: 1342095 · Received March 11, 2009

    Report

    Report Number
    2112667-2009-00017
    Event Type
    Other
    Date Received
    March 11, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 11, 2009
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CAD
    PMA / PMN Number
    K913593
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT WAS CHECKED BY A GE FIELD SERVICE REPRESENTATIVE. THE EQUIPMENT WAS FOUND TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS, EXCEPT THE TEC 6 VAPORIZER WAS FOUND TO HAVE OUTPUT HIGH TO SPECIFICATION. THE HOSPITAL WILL NOT RELEASE THE VAPORIZER TO GE FOR FURTHER INVESTIGATION. IT SHOULD BE NOTED THAT, ACCORDING TO GE HEALTHCARE RECORDS, THIS UNIT HAS NOT BEEN SERVICED SINCE 2004. AS STATED IN THE TEC 6 OPERATION AND MAINTENANCE MANUAL, THE TEC 6 VAPORIZER REQUIRES SERVICING EVERY 2 YEARS. FURTHER INVESTIGATION INTO THE ALLEGED COMPLAINT CANNOT BE PERFORMED UNTIL THE HOSPITAL RELEASES THE TEC 6 VAPORIZER FOR INVESTIGATION. IF THE VAPORIZER IS RELEASED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE IN THE RECOVERY ROOM, THE PATIENT REPORTED HAVING A DEGREE OF RECALL DURING A PROCEDURE. THE TEC 6 VAPORIZER WAS INITIALLY USED IN THE CASE, AND THE AGENT MONITOR REPORTEDLY DID NOT PICK UP ANY AGENT. THE CLINICIAN REPORTEDLY SWITCHED TO SEVO. THE ANESTHESIA MONITOR DID NOT PICK UP ANY AGENT FOR 5 MINUTES, THEN THE MONITOR READ VERY LOW OUTPUT, AND THEN IT REPORTEDLY DID NOT READ ANY AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 CALIBRATED VAPORIZER CAD DATEX-OHMEDA 1107-9101-000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other