BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIQ S7 DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 2915414 · Received January 9, 2013

    Report

    Report Number
    9710090-2013-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    GE ULTRASOUND KOREA CO., LTD.
    Product Code
    IYN
    PMA / PMN Number
    K122114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED FOR THE LOGIQ S8 ON MFR REPORT NO. 9710090-2012-00004. THE PRIMARY DIFFERENCE BETWEEN THE TWO SYSTEMS IS THE CHANNEL COUNT. THE LOGIQ S7 HAS 128/64 CHANNELS, AND THE LOGIQ S8 HAS 192 CHANNELS. ALL OTHER FEATURES ARE VIRTUALLY THE SAME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE SERIAL NUMBER OF THE DEVICE IS NOT AVAILABLE. THE DEVICE MFR DATE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING AN INTERNAL INVESTIGATION BY THE MFR, IT WAS DISCOVERED THAT WHEN 'FLOW MODEL' IS SELECTED IN COLOR FLOW OR PULSED DOPPLER MODE WITH CARDIAC APPLICATION, THE ACOUSTIC OUTPUT INCREASES ABOVE ITS DESIGN SPECIFICATION AND THE PROBE SURFACE BECOMES HOT. THERE WAS NO REPORT OF INJURY. IN ADDITION TO RAPIDLY INCREASED SURFACE TEMPERATURE OF THE PROBE, THIS EVENT CAUSED THE PROBE ACOUSTIC OUTPUT TO INCREASE WELL ABOVE THE FDA LIMIT OF 720 MW/CM^2, THUS CAUSING THE DEVICE TO FAIL ITS DESIGN SPECIFICATIONS RELATING TO ULTRASOUND EMISSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12685 LOGIQ S7 DIAGNOSTIC ULTRASOUND SYSTEM ULTRASONIC PULSED DOPPLER IMAGING SYSTEM IYN GE ULTRASOUND KOREA CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1