BEUDAMED
    FDA Adverse Event Other Summary report: N

    EUB-6500 ULTRASOUND

    MDR report key: 1622867 · Received March 3, 2010

    Report

    Report Number
    8030405-2010-00005
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    ITX
    PMA / PMN Number
    K013723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HITACHI APPLICATIONS VISITED AGAIN ON (B)(4)2010. THE ORIGINAL DVT IMAGES WERE REVIEWED FOR THE FIRST TIME BY THE SAME CLINICAL APPLICATIONS SPECIALIST FROM (B)(4) AND OUR ULTRASOUND CLINICAL SCIENCE MANAGER. IN THEIR OPINION, THE PT'S IMAGES ARE CONSISTENT WITH A DVT AND INCLUDED COLOR FLOW IMAGING AND VEIN COMPRESSION TESTS COMMONLY USED FOR SUCH A DIAGNOSIS. HOWEVER, THE ARTIFACT IDENTIFIED ON (B)(4)2010 DOES NOT HAVE THE SAME APPEARANCE. ADDITIONAL TESTS WERE DONE DURING THE (B)(4)2010 VISIT AND WERE CONSISTENT WITH A ROUTINE REVERBERATION ARTIFACT. THE ARTIFACT CAN BE MINIMIZED BY SYSTEM USER ADJUSTMENTS (ACOUSTIC POWER/FREQUENCY, ETC.) AND DIFFERENT PROBE POSITIONING. DURING THE APPLICATIONS VISIT ON (B)(4), THE HITACHI REPRESENTATIVE DID EXCLUDE THE ULTRASOUND TRANSDUCER AS A POSSIBLE CAUSE OF THE ARTIFACT. HITACHI SERVICE VISITED ON (B)(4)2010 AND NOTED NO EVIDENCE OF A MALFUNCTION. AS OF (B)(4), THE SITE REPORTED THAT THEY ARE NOT USING THE SYSTEM. HITACHI WILL CONTINUE TO WORK WITH THE SITE, BUT SEES NO EVIDENCE OF EQUIPMENT MALFUNCTION AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(4)2010, HITACHI CLINICAL APPLICATIONS WAS ON SITE FOR ROUTINE APPLICATIONS ON A HITACHI EUB-6500 ULTRASOUND SYSTEM. WHILE TESTING THE UNIT, THE APPLICATIONS SPECIALIST NOTICED AN IMAGE ARTIFACT WHILE PERFORMING 2D SCANNING ON A VOLUNTEER'S CAROTID ARTERY. AT THAT TIME, THE SITE REPORTED TO THE HITACHI REPRESENTATIVE THAT THEY HAD RECENTLY SCANNED A PT AND DETECTED A DEEP VEIN THROMBOSIS (DVT) IN THE COMMON FEMORAL VEIN. THE TECHNOLOGIST LINKED THE DVT DIAGNOSIS TO THE ARTIFACT BECAUSE OF ITS SIMILAR APPEARANCE. (THE DVT PT WAS PRESCRIBED COUMADIN. THE PT WAS SCANNED LATER ON ANOTHER ULTRASOUND AT ANOTHER FACILITY AND THERE WAS NO EVIDENCE OF THE DVT. THE PT WAS TAKEN OFF THE MEDICINE.) THE PT'S IMAGES WERE NOT AVAILABLE AT THE TIME, BUT OUR TESTING SHOWED THE ARTIFACT DID NOT APPEAR ON COLOR FLOW IMAGING NOR PULSE WAVE DOPPLER IMAGING ROUTINELY USED TO CONFIRM DVT, SO IT WAS DISCOUNTED AS A REVERBERATION ARTIFACT COMMON TO ULTRASOUND IMAGING. THE SITE SCANNED A HEALTHY VOLUNTEER ON (B)(6)2010 AND SAW A SIMILAR IMAGE ARTIFACT. THEY CALLED HITACHI CLAIMING THAT THE SYSTEM WAS MALFUNCTIONING AND HAD CAUSED A MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUB-6500 ULTRASOUND SYSTEM, IMAGING, PULSEDDOPPLER, ULTRASOUND ITX HITACHI MEDICAL CORP. EUB-6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other