BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEEX PROBE

    MDR report key: 2357698 · Received December 2, 2011

    Report

    Report Number
    2357698
    Event Type
    Malfunction
    Date Received
    December 2, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 18, 2011
    Manufacturer
    SONOSITE, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A SURGICAL PROCEDURE THE DOCTOR PLACED A FEMORAL NERVE CATHETER AND ATTEMPTED TO PERFORM A SCIATIC NERVE BLOCK. THE ULTRASOUND M-TURBO UNIT AND TEEX PROBE DID NOT FUNCTION AND BOTH WERE IMMEDIATELY REMOVED FROM SERVICE. THERE WAS A BRIEF DELAY WHILE ANOTHER ULTRASOUND UNIT AND PROBE WERE OBTAINED AND SET UP SO THE DOCTOR COULD PERFORM THE SCIATIC NERVE BLOCK. BIOMEDICAL ENGINEERING RECEIVED THE M-TURBO UNIT AND TEEX PROBE AND WERE TOLD THAT THE TEEX PROBE BUTTON DOES NOT WORK. BIOMED SET UP AND POWERED UP THE M-TURBO UNIT, AND WHEN THE PROBE WAS CONNECTED TO THE UNIT, AN ERROR CODE 9071 WAS DISPLAYED. THE MANUFACTURER TECHNICIAN SUPPORT SERVICE WAS CONTACTED AND THE ACTION TAKEN WAS TO EXCHANGE THE TEEX PROBE WITH A NEW ONE. THE M-TURBO WAS PLACED BACK IN SERVICE WITH THE NEW PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEEX PROBE TRANSDUCER, ULTRASONIC, DIAGNOSTIC, TEE ITX SONOSITE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *