BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN ULTRASOUND SYSTEM, REMANUFACTURED

    MDR report key: 2176687 · Received October 10, 2008

    Report

    Report Number
    3032367-2008-00007
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 18, 2008
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR TITAN ULTRASOUND SYS ASSERTED (BLUE SCREEN, ERROR CODE) WHILE ADJUNCTIVELY BEING USED DURING AN RF VASCULAR ABLATION PROCEDURE. BECAUSE THE TITAN WAS TEMPORARILY UNAVAILABLE, THE DR CONTINUED THE PROCEDURE WITHOUT THE VISUAL AID PROVIDED BY THE ULTRASOUND. THE DR WAS ABLE TO RESTART THE TITAN. THE PT WAS NOT HARMED, AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY. NO CLINICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN ULTRASOUND SYSTEM, REMANUFACTURED DIAGNOSTIC ULTRASOUND SYSTEM IYO SONOSITE, INC. P04240-15R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other