BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 4960870 · Received July 30, 2015

    Report

    Report Number
    9615916-2015-00002
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 28, 2015
    Manufacturer
    INTELERAD MEDICAL SYSTEMS INCORPORATED
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ORDER TO CORRECT THIS ISSUE, INTELERAD WILL: PROVIDE THE AFFECTED CLIENTS WITH A LIST OF STUDIES THAT WERE AFFECTED AND POSSIBLY RECOVER THE MISSING IMAGES. DEPLOY A SOFTWARE UPDATE THAT INCLUDES A FIX AND MITIGATION TO ALL CLIENTS WHERE THE ISSUE COULD POTENTIALLY OCCUR. THIS WILL BE DONE TENTATIVELY. PERIODICALLY AUDIT ALL AFFECTED CLIENT, ANY NEW OCCURRENCES OF THIS ISSUE UNTIL THE MITIGATION (SOFTWARE UPDATE) IS IN PLACE. THE SOFTWARE UPDATE WILL INCLUDE ONLY BUG FIXES - YOUR WORKFLOW WILL NOT BE AFFECTED. THE UPDATE WILL RESULT IN ABOUT 5 MINUTES OF DOWNTIME PER SERVER AS WE PERFORM A FULL SERVICE RESTART. IMPACT ON USERS WILL BE MINIMAL, IF ANY. CORRECTIVE ACTION CALENDAR: FOR ALL CLIENTS WITH PACS VERSION 4-5-1 OR HIGHER, THE SOFTWARE UPDATE WILL BE DEPLOYED WITHIN A TIMEFRAME TO BE AGREED WITH CLIENTS (COMPLETION ESTIMATED BY END OF MARCH 2016).

    Description of Event or Problem · 1

    NO PATIENT INCIDENT REPORTED AT THIS MOMENT - THIS ISSUE IS DOCUMENTED AS A PRECAUTION. FIVE RELATED CUSTOMER COMPLAINTS ((B)(4)) WERE REGISTERED AND INVESTIGATED FROM OCT 2014 TO JUNE 2015 FOR RELATED ISSUES. THE INVESTIGATION OF THESE COMPLAINTS LED TO THE DISCOVERY OF ISSUES WITH IMAGE INGESTION. BUGS IDENTIFIED: (B)(4) LDS: LDS: FAILED TO INGEST IMAGE WITH OVERLAYS BELONGING TO 60XX GROUP HAVING ALPHANUMERIC ID (IE, 600A) (B)(4) LDS: ROWS STUCK IN INCOMING_FILES DUE TO FILES MISSING IN THE INCOMING FILES FOLDER. INVESTIGATION: INVESTIGATION OF THE LOGS IN (B)(4) REVEALED THAT SOME OF THE EXPECTED OVERLAY FILES WERE NOT FOUND ON THE FILE SYSTEM; THIS LED TO DISCOVERY OF THE MISSING FILES LEFT BEHIND AT AN EARLIER STAGE OF IMAGE INGESTION. ROOT CAUSE OF THE PROBLEM: DUE TO THE ASYNCHRONOUS NATURE OF IMAGE INGESTION PROCESSING, A FAILURE AT THE EARLY STAGES OF THE INGESTION PROCESS CAN LEAD TO IMAGES NOT BEING VISIBLE TO THE END USER. THERE IS NO INDICATION TO THE USER THAT THIS HAS OCCURRED. REASON FOR POSSIBLE PATIENT SAFETY: THE RADIOLOGIST MAY PROVIDE A DIAGNOSIS WITHOUT BEING AWARE THAT IMAGES ARE MISSING. DESIGN MITIGATION TO REDUCE THE RISK: PROPOSED NEW MITIGATION: THE PACS WILL REPORT PROBLEMS INGESTING IMAGES AND INDICATE SUCH ISSUES TO THE USER ((B)(4)). THIS MITIGATION WILL BE INCLUDED IN A COMING SOFTWARE RELEASE. (B)(4): LDS: EXPOSE BROKEN SERIES TO USER (WARN ABOUT ADDITIONAL IMAGES PENDING INGESTION WHEN VIEWING IMAGES). DETECTABILITY OF PROBLEM: UNTIL THE SOFTWARE UPDATE THAT WILL INCLUDE THE PROPOSED MITIGATION IS INSTALLED ON THE CLIENT'S SYSTEM, THE USER MAY NOT BE AWARE THAT SOME IMAGES MAY BE MISSING. HOWEVER, IF THE CLIENT'S SYSTEM HAS OTHER MECHANISMS TO VERIFY IMAGE COUNT BETWEEN SOURCE AND DESTINATION, THEN THE USER MIGHT BE ABLE TO KNOW ABOUT THE DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495273 INTELEPACS PICTURE ARCHIVING AND COMMUNICATION LLZ INTELERAD MEDICAL SYSTEMS INCORPORATED VERSIONS 4.5.1 AND UP

    Patients

    Seq Age Sex Outcome Treatment
    1