BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCANVAS RIS/PACS

    MDR report key: 9777552 · Received March 2, 2020

    Report

    Report Number
    3012075008-2020-00003
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    June 13, 2017
    Report Date
    March 2, 2020
    Manufacturer
    SYNAPTIVE MEDICAL INC.
    Product Code
    LLZ
    PMA / PMN Number
    K110332
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SYNAPTIVE REP USED "GOTOASSIST" TO VIEW IMAGES DIRECTLY. THE REP FOUND THE WINDOW CENTER AND WINDOW WIDTH DICOM TAG VALUES WERE SET TO 2047 AND 4096 RESPECTIVELY. THE PROBE TOOL SHOWED THAT THE BRIGHTEST WHITE HAD VALUE OF 60-70, BLACKS WERE 256. MANUAL WINDOW/LEVEL APPLIED TO MAKE IMAGE VISIBLE WAS IN 250/150 RANGE. THE REP FOUND: BITS STORED (0028,0101) VALUE SET TO 12. AFTER CORRECTING THE VALUE TO 16 AND SAVING IMAGE IT DISPLAYED PROPERLY UPON RELOADING. THE ISSUE WAS FOUND TO BE SIMILAR TO FEED-3544 (REPORTED AS 3012075008-2020-00001). IMAGE IS ACTUALLY 16-BIT, BUT DICOM HEADER TAG (0028,0101) INCORRECTLY STATES IT IS 12-BIT. LEFT CUSTOMER TO CONTACT THE SITE THAT PRODUCED THE DVD TO SEE WHY THE DICOM TAG VALUE DOES NOT MATCH WHAT IS IN THE PIXEL DATA. THIS WAS LOGGED AS AND ENHANCEMENT REQUEST FOR IMPROVED INTEROPERABILITY WITH OTHER DICOM VENDORS. ON 04-FEB-2020, A SOFTWARE DEFECT WAS DISCOVERED WHILE INVESTIGATING AN ISSUE REGARDING A RESEARCH DEVICE. THIS LED TO A RETROSPECTIVE ANALYSIS OF FEEDBACK TICKETS. THE RESEARCH DEVICE USES THE SAME JPEG 2000 CODEC AS THE DEVICE DESCRIBED IN THIS REPORT. WHILE THE LIKELIHOOD OF POTENTIAL SERIOUS HEALTH CONSEQUENCES IS REMOTE, THE USE OF THE DEFECTIVE SOFTWARE ASSOCIATED COULD RESULT IN MISDIAGNOSIS, POTENTIALLY CAUSING SIGNIFICANT INDIRECT HARM NECESSITATING MEDICAL INTERVENTION THAT IS SERIOUS BUT TEMPORARY. THIS DEFECT IS ONLY ENCOUNTERED IN SELECT SCENARIOS, WHERE A MODALITY PRODUCES IMAGES THAT ARE COMPRESSED USING JPEG 2000, AND THE IMAGE PIXEL DATA IS LESS THAN 16-BIT, AND THE "BITNESS" OF THE COMPRESSED DATA STREAM DOES NOT MATCH THAT OF THE IMAGE PIXEL DATA. THE OUTCOME OF THE ABOVE IS A LOSS OF PRECISION IN THE DECOMPRESSED PIXEL DATA, WHICH CAUSES THE SYMPTOMS THAT WERE REPORTED BY THE CUSTOMER. THE ROOT CAUSE IS THAT A SOFTWARE DEFECT FOUND IN THE DEVICE THAT IS ENCOUNTERED WHEN IT IS USED WITH NON-DICOM COMPLIANT JPEG 2000 COMPRESSED IMAGES. THE SOFTWARE IMPROPERLY USES THE DICOM BIT DEPTH (I.E. THE BITS STORED TAG) TO DECOMPRESS THE COMPRESSED PIXEL DATA STREAM FOR DISPLAY, INSTEAD OF THE BIT DEPTH THAT IS ENCODED IN THE COMPRESSED PIXEL DATA STREAM ITSELF. IN NON-DICOM COMPLIANT IMAGES WHERE THE DICOM AND COMPRESSED PIXEL DATA STREAM BIT DEPTHS DO NOT MATCH, THE SOFTWARE OUTPUTS AN IMAGE WITH SOME LOSS OF PRECISION IN THE DECOMPRESSED PIXEL DATA. IN THESE SCENARIOS, THE MODALITY PRODUCING THE IMAGE IS ITSELF ALSO NOT COMPLIANT TO DICOM PS3.5 8.2.4. MDR REPORTS: 3012075008-2020-00001, 3012075008-2020-00002, AND 3012075008-2020-00004 HAVE THE SAME ROOT CAUSE. A CAPA HAS BEEN OPENED AND RECALL INITIATED TO ADDRESS THE ISSUE IN AFFECTED DEVICES.

    Description of Event or Problem · 1

    ON 13-JUN-2017 A CUSTOMER REPORTED THAT IMAGES THAT APPEARED VERY BRIGHT (WASHED OUT) WHEN LOADED IN CLEARCANVAS WORKSTATION PERSONAL EDITION 13.1. SHE RECEIVED THE IMAGES VIA A DVD. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240384 CLEARCANVAS RIS/PACS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ SYNAPTIVE MEDICAL INC. PERSONAL EDITION WORKSTATION 13.1

    Patients

    Seq Age Sex Outcome Treatment
    1