BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE RADIOLOGY PACS

    MDR report key: 18377215 · Received December 21, 2023

    Report

    Report Number
    3004972322-2023-00003
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Report Date
    September 23, 2024
    Manufacturer
    FUJIFILM HEALTHCARE AEMERICAS CORPORATION
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K160108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    REF COMP#(B)(4). IT WAS REPORTED THAT THE IMAGES INITIALLY DISPLAY THE EXPECTED SIZE BUT IF THEY SCROLL THROUGH THE IMAGES THE SIZE SHRINKS TOO VERY SMALL. THIS WAS INVESTIGATED AND AS PART OF THE INVESTIGATION IT WAS FOUND THAT IF A USER DOES MEASUREMENTS ON THESE IMAGES THE MEASUREMENTS WILL BE INCORRECT. THE ISSUE AS REPORTED INITIALLY WOULD BE A WORKFLOW ISSUE WITH MINOR SEVERITY. HOWEVER, THE MEASUREMENT ISSUE IS A MAJOR SEVERITY. THE FMEA FOR THE MEASUREMENT ISSUE IS: 9018-00: IMAGE MANAGEMENT FEATURES (PRINT, MEASUREMENT, OVERLAY, ANNOTATION, ETC.) PROVIDING INCORRECT DATA - SOFTWARE DEFECT. TECHNICAL INVESTIGATION: THE CODE INADVERTENTLY USES THE PIXEL SPACING OF THE BREAST TOMO SERIES ON THE SECONDARY CAPTURE IMAGE. SECONDARY CAPTURE IMAGES TYPICALLY DO NOT HAVE PIXEL SPACING AS IT WAS FOR THE CASE REPORTED. BASED ON THE MODALITY VENDOR MG SECONDARY CAPTURE IMAGES MAY CONTAIN PIXEL SPACING AND IN SUCH CASE THIS ISSUE DOES NOT EXIST. MEASUREMENTS SHOULD NOT BE PERFORMED WITHOUT A VALID PIXEL SPACING. IN THE REPORTED CASE THE SOFTWARE APPLICATION APPLIED THE INCORRECT PIXEL SPACING TO THE SECONDARY CAPTURE IMAGE AND AS A RESULT THE MEASUREMENT FUNCTIONALITY CAN BE PERFORMED BY THE END USER THAT PRODUCES INCORRECT MEASUREMENTS. THIS NEEDS TO BE CORRECTED. CLINICAL ASSESSMENT/IMPACT: THE CLINICAL REVIEW CONDUCTED CONFIRMS THE TECHNICAL INVESTIGATION. A CORRECTION IS NEEDED. IF THE RADIOLOGIST RELIES ON THE MEASUREMENT PROVIDED, HE/SHE MAY MISDIAGNOSE. THE RADIOLOGISTS DO KNOW THAT IMAGES WITHOUT PIXEL SPACING NEED TO BE CALIBRATED AND IN SOME CASES CAN IDENTIFY SUCH IMAGES BY VISUAL CLUES SUCH AS BURNED IN ANNOTATIONS. HOWEVER, THIS MAY NOT ALWAYS BE OBVIOUS AND IN SOME CASES THE RADIOLOGISTS WILL NOT KNOW THAT THE IMAGE IN QUESTION HAS NO PIXEL SPACING UNLESS MEASUREMENTS ARE NOT SHOWN OR ARE PREVENTED VIA THE USER INTERFACE. THERE IS A RISK OF USING INCORRECT MEASUREMENTS AS PART OF THE DIAGNOSIS AND POTENTIALLY MISDIAGNOSING THE PATIENT. ESCALATION NUMBER: (B)(4). ESCALATED TO NS3 BUG NUMBER (B)(4). TROUBLESHOOTING: FUJIFILM SERVICE HAS THE IMAGES IN BOX. LOADED INTO VM FOR 5.7 AND ALSO 7.3.000 ( SITE IS ON 7.3.100) WHEN THE STUDY LOADS IN A SYSTEM MAMMO PROTOCOLS THE IMAGES LOOK OK. THERE ARE SECONDARY CAPTURES AND IN THE SERIES THAT HAS 2 IMAGES, IF SCROLL TO THE SECOND IMAGE AND SCROLL BACK IN V7 THE IMAGE IS VERY TINY. SERVICE HAS TRIED TO PLAY WITH THE ZOOM TO BREAST BOUNDS, CREATED NEW PROTOCOLS- SAME BEHAVIOR. IF OPEN UP THE IMAGE AND SCROLL THROUGH- THE IMAGES FUNCTIONS AS EXPECTED, IF U DOUBLE CLICK ON THE THUMBNAIL AND LOAD IN THE SERIES VIEWER IT BEHAVES AS EXPECTED AS WELL. THIS IS A CHANGE FROM WHAT HAPPENS IN V5.7 ( VIDEO INCLUDED).

    Additional Manufacturer Narrative · 0

    REF COMP (B)(4). THE SECOND SUPPLEMENTAL MDR IS BEING SUBMITTED IN REGARD TO FDA'S EMAIL TO HCUS ABOUT UDI CORRECTION IN REFENCE WITH GUDID. FOLLOWINGS ARE THE CORRECTED SECTIONS IN THE REPORT. D1, G1

    Additional Manufacturer Narrative · 0

    REF COMP #(B)(4). THE THIRD SUPPLEMENTAL MDR IS BEING SUBMITTED IN REGARD TO CORRECT MANUFACTURER CONTACT INFORMATION G1.

    Description of Event or Problem · 0

    ON (B)(6), 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING SYNAPSE SOFTWARE. IT WAS REPORTED THAT THE SITE UPGRADED FROM V5.7 TO V. 7.3 LAST MONTH. IN V5.7, WHEN IMAGES WERE ANNOTATED IN VRAD AND SENT TO SYNAPSE, THE IMAGE SIZE (MG ONLY) WAS MAINTAINED SINCE THE UPGRADE TO V7.3.002. THE IMAGES INITIALLY DISPLAYED THE EXPECTED SIZE BUT IF THEY SCROLL THROUGH THE IMAGES, THE SIZE SHRINKS TO VERY SMALL. THE SITE HAS TRIED TO ADJUST THE DIFFERENT ZOOM FACTORS AND USING JUST A SYNAPSE DEFAULT READING PROTOCOL WITH NO LUCK. NO ADDITIONAL INFORMATION PROVIDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169507 SYNAPSE RADIOLOGY PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ FUJIFILM HEALTHCARE AEMERICAS CORPORATION 890000004 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown