BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEC 7

    MDR report key: 1321744 · Received February 20, 2009

    Report

    Report Number
    2112667-2009-00015
    Event Type
    Other
    Date Received
    February 20, 2009
    Date of Event
    January 15, 2009
    Report Date
    February 20, 2009
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CAD
    PMA / PMN Number
    K012924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE PERFORMED A CHECKOUT OF THE EQUIPMENT AND FOUND IT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATION. THE CLINICIAN REPORTED TO GE HEALTHCARE THAT HE INADVERTENTLY THOUGHT THE TEC 7 VAPORIZER WAS SIMILAR TO AN ELECTRONIC VAPORIZER WHEREIN IT WOULD ALARM FOR LOW AGENT. AS STATED IN THE TEC 7 USER'S REFERENCE MANUAL: "WHEN FILLING THE TEC 7 VAPORIZER, OBSERVE THE FOLLOWING: PERIODICALLY CHECK THE AGENT LEVEL. THE VAPORIZER SHOULD BE REFILLED AT APPROPRIATE INTERVALS. THE VAPORIZER IS DESIGNED TO FUNCTION ACCORDING TO SPECIFICATION, AS LONG AS THERE IS AGENT VISIBLE ABOVE THE MARK."

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT, UPON AWAKENING, PATIENT STATED THAT SHE HAD BLURRY INTRAOPERATIVE AWARENESS FOR A FEW MINUTES AT BEGINNING OF CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 7 CALIBRATED VAPORIZER CAD DATEX-OHMEDA M107626

    Patients

    Seq Age Sex Outcome Treatment
    1