BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6T-RS ULTRASOUND PROBE

    MDR report key: 1513232 · Received October 13, 2009

    Report

    Report Number
    9610482-2009-00002
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 13, 2009
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K033139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE RECEIVED THE PROBE FOR INVESTIGATION. THE HIGH POTENTIAL TEST FAILED TO FIND LEAKAGE CURRENT. A PRESSURE TEST WAS APPLIED AND NO BITE HOLES WERE NOTED. THE PROBE WAS CONNECTED TO AN IN-HOUSE VIVID SYSTEM AND FOUND TO BE FUNCTIONAL. WHEN THE PROBE WAS FIRST RECEIVED, IT WAS NOTED THAT THE PROBE BRAKES WERE APPLIED, WHICH WAS POSSIBLY THE CAUSE OF THE PERCEIVED STIFFNESS. NO DEVICE FAILURES WERE NOTED. THE CUSTOMER WAS INFORMED OF THESE INVESTIGATIONAL FINDINGS AND WAS ADVISED NOT TO ROTATE THE PROVE WHILE THE ANGULATIONS BREAKS ARE APPLIED, AS THIS CAN CAUSE MECHANICAL FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 6T TRANSESOPHAGEAL PROBE WAS TOO STIFF, AND THEY HAVE DIFFICULTY WITH THE PROBE SUCH THAT THE STIFFNESS MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY IN SURGICAL PATIENTS WHEN THE PROBE IS IN PLACE FOR 3 TO 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6T-RS ULTRASOUND PROBE TRANSESOPHAGEAL ULTRASOUND IYN GE VINGMED ULTRASOUND AS KN100093

    Patients

    Seq Age Sex Outcome Treatment
    1