BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID I

    MDR report key: 1582698 · Received January 5, 2010

    Report

    Report Number
    9615849-2010-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    November 18, 2009
    Report Date
    January 5, 2010
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
    Product Code
    ITX
    PMA / PMN Number
    K061525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(4): DURING THE COURSE OF A MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. THE (B)(6) SUFFERED FROM REPEATED MALFUNCTIONS WITHOUT RECOVERY. THE SYSTEM REQUIRED RE-BOOTING TO CONTINUE FUNCTION. THE FIRST EVENT OCCURRED AFTER CHANGING THE PROBE FROM TEE TO EPIAORTIC. THE SYSTEM WOULD NOT RECOGNIZE EITHER PROBE AND DISPLAYED A "PROBE REMOVED" ERROR REQUIRING REBOOT. THE NEXT EVENT OCCURRED WHILE COMING OFF OF CARDIOPULMONARY BYPASS AND DE-AIRING. THE SCREEN IMAGE WAS FROZEN AND UNABLE TO BE FREED. THIS ALSO REQUIRED A REBOOT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM ITX GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. 2420015

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR