BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGE ULTRASOUND SYSTEM, 1.2.3, ROHS

    MDR report key: 7143850 · Received December 22, 2017

    Report

    Report Number
    3032367-2017-00003
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 12, 2017
    Report Date
    December 21, 2017
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Product Code
    IYN
    PMA / PMN Number
    K113156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DEVICE WAS RETURNED TO SONOSITE FOR EVALUATION, DURING WHICH TIME IT WAS INSPECTED EXTERNALLY AND FOR PROPER FUNCTIONALITY. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED AND NO EVIDENCE THAT A DEVICE MALFUNCTION WAS OBSERVED. THE REPORTED INCIDENT WAS REVIEWED BY THE CLINICAL AFFAIRS DEPARTMENT WHO CONCLUDED THE FOLLOWING RESULTS: A QUALIFIED USER OF AN ULTRASOUND SYSTEM IS EXPECTED TO KNOW HOW TO MEASURE A FETAL HEART RATE, WHICH IS BEST MEASURED USING M-MODE (PREFERABLE METHOD) OR DOPPLER MODE. WHEN USING EITHER MODE, ONCE THE MODE IS INITIATED, THE D/M LINE MUST BE PLACED OVER THE MOVING STRUCTURES OF THE FETAL HEART IN ORDER TO PRODUCE A SCROLLING TRACE WHICH IS THEN MEASURED USING THE HR MEASUREMENT GOAL POSTS. HEART RATE MEASUREMENT REQUIRES GOOD VISUALIZATION OF THE FETAL HEART STRUCTURES. AT TIMES, ON A LATE THIRD TRIMESTER OB PATIENT, IT MAY REQUIRE MULTIPLE TRANSDUCER POSITIONS TO FIND THE BEST VIEW TO PERFORM A DOPPLER OR MODE TRACE OF THE FETAL HEART. THE PATIENT MAY NEED TO GET UP AND MOVE AROUND AND THEN BE RESCANNED IF THE FETUS IS IN A "SPINE-UP" POSITION, OR THE DEPTH CONTROL MUST BE ADJUSTED TO INCLUDE A COMPLETE VIEW OF THE FETAL CHEST AREA. USING 2D MODE, THERE WILL ONLY BE UNQUANTIFIED HEART MOTION VISUALIZED, IF THE USER HAS POSITIONED THE FETAL HEART TO BE INCLUDED IN THE FIELD OF VIEW. IN 2D MODE, THERE IS NO HEART RATE MEASUREMENT, AS THERE IS NO SCROLLING DATA BUT POSITIVE FETAL HEART MOTION MAY BE RECORDED AND SAVED AS A CLIP ON THE SYSTEM THAT CAN BE PLAYED BACK IN REVIEW AND MOTION VIEWED ON PLAYBACK. BY JUST PRESSING THE DOPPLER BUTTON WITHOUT POSITIONING THE DLINE ON THE AREA OF INTEREST, IT IS UNLIKELY TO PRODUCE ANY USEABLE DATA TO MEASURE. THE D/M LINE MUST BE POSITIONED CORRECTLY OVER THE MOVING STRUCTURES IN ORDER TO PRODUCE A PULSED WAVEFORM OR HEART TRACING. IF THE USER IS UNABLE TO OBTAIN GOOD QUALITY IMAGES OF THE FETAL HEART THEN A MORE CLINICAL APPROACH USING A STETHOSCOPE OR NON-STRESS TEST SHOULD BE UTILIZED TO ENSURE THE PRESENCE OF FETAL CARDIAC ACTIVITY BEFORE ANY INTERVENTION IS PERFORMED. IT WOULD BE MOST HELPFUL TO VIEW THE RECORDED ULTRASOUND EXAMS OF THESE PARTICULAR PATIENTS, IN ORDER TO BEST UNDERSTAND WHAT THE DIFFICULTY IN USE OF THE ULTRASOUND SYSTEM WAS. ADEQUATE VIEWS OF THE FETUS AND FETAL HEART MUST BE OBTAINED BY THE USER BEFORE ANY DIAGNOSIS IS MADE. PROPER USE OF DOPPLER AND MODE MODES IS REQUIRED FOR A HEART RATE MEASUREMENT, AND IT WAS STATED IN THE COMPLAINT THAT THE USER WAS ONLY USING 2D MODE. WITH THE AVAILABLE INFORMATION AND ANALYSIS, IT HAS BEEN CONCLUDED THAT THERE WAS NO FAILURE OF DEVICE AND THE CAUSE OF THE REPORTED ISSUE WAS DUE TO USE ERROR.

    Description of Event or Problem · 1

    WHILE MONITORING A PATIENT IN LABOR, THE CUSTOMER ALLEGED THAT THE DEVICE WAS UNABLE TO DETECT A FETAL HEART RATE AFTER THE PATIENT'S MEMBRANES RUPTURED. A BEDSIDE ULTRASOUND WAS PERFORMED IN AN ATTEMPT TO DETECT THE FETUS' HEART RATE, HOWEVER, THE CUSTOMER ALLEGES THAT THE DEVICE WAS NOT ABLE TO DO SO WHILE USING 2D MODE. AS A RESULT, THE PATIENT WAS RUSHED INTO AN EMERGENCY CESARIAN SECTION SURGERY. THE CHILD WAS OBSERVED TO HAVE BEEN IN A BREECH POSITION BUT WAS SUCCESSFULLY BIRTHED WITH NO OBVIOUS CONCERNS OR HARM. NO HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922302 EDGE ULTRASOUND SYSTEM, 1.2.3, ROHS DIAGNOSTIC ULTRASOUND SYSTEM IYN FUJIFILM SONOSITE, INC. P15000-63

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R