BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO IMAGING

    MDR report key: 1333732 · Received January 22, 2009

    Report

    Report Number
    2240869-2009-00003
    Event Type
    Malfunction
    Date Received
    January 22, 2009
    Date of Event
    October 29, 2008
    Report Date
    January 19, 2009
    Manufacturer
    SIEMENS AG
    Product Code
    LLZ
    PMA / PMN Number
    K071114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SO FAR NO DIRECT CONSEQUENCES ARE REPORTED OR KNOWN. FOLLOWING PREVENTIVE AND CORRECTIVE MEASURES ARE PLANNED: ANALYSIS OF THE ROOT CAUSE TOGETHER WITH EMC AND DECISION ABOUT A POSSIBLE SOLUTION VIA A SW PATCH OR CONFIGURATION. DEPENDING FROM #1 ANALYSIS OF POTENTIALLY AFFECTED CUSTOMER INSTALLATIONS. CREATION OF A CUSTOMER SAFETY ADVISORY NOTICE FOR ALL POTENTIALLY AFFECTED CUSTOMERS. IMPLEMENTATION OF A CHECK TOOL TO DETERMINE THE DEFECTIVE SAVED IMAGE DATA ON CUSTOMER SITE. PERFORM THE CHECK ON SITE WITH THE TOOL UNDER #4 TO DETERMINE THE DEFECTIVE SAVED IMAGE DATE. IMPLEMENTATION OF A CORRECTION TOOL TO TEMPORARILY DEARCHIVE THE AFFECTED STUDIES FROM LONG TERM ARCHIVE TO SHORT TERM ARCHIVE. THE TOOL WILL SUBSTITUTE AFFECTED DEFECTIVE IMAGES WITH DUMMY IMAGES. THIS WILL ENSURE THAT SERIES WITH DEFECTIVE SINGLE IMAGES WILL BE ABLE TO BE PREFETCHED LATER. PERFORM THE CORRECTION ON SITE WITH THE TOOL UNDER #6 PLANNED. THIS EVENT OCCURED IN (B) (6): HOSPITAL (B) (6), DR. (B) (6).

    Description of Event or Problem · 1

    ON 2008-12-05 WE HAVE BEEN NOTIFIED THAT THE PREFETCHING OF PRIOR EXAMINATIONS FROM THE LONG TERM ARCHIVE (EMC) TO THE SYNGO IMAGING PACS DOES NOT WORK. THAT MEANS THAT THE DOCTORS ARE NOT ABLE TO EVALUATE THE COURSE OF DISEASE E.G. OF CANCER PATIENTS BASED ON THE IMAGE DATA FROM PRIOR EXAMINATIONS. USUALLY IMAGE DATA AND REPORT DATA FROM PRIOR EXAMINATION ARE USED TO EVALUATE THE COURSE OF DISEASE COMPARED TO THE ACTUAL EXAMINATION. FIRST ANALYSIS SHOWED THAT THE ROOT CAUSE IS AN DEFECTIVE BEHAVIOR IN THE DATA TRANSPORT LAYER OF THE NFS (NETWORK FILE SYSTEM) CONNECTION BETWEEN THE LONG TERM ARCHIVE OF EMC AND THE SYNGO IMAGING PACS SYSTEM. SYNGO IMAGING PACS IS ARCHIVING IMAGE DATA VIA THIS NFS INTERFACE ON THE EMC LONG TERM ARCHIVE. AN ERROR ON THE EMC LONG TERM ARCHIVE CAUSED THAT DATA SENT FROM SYNGO IMAGING HAVE BEEN ARCHIVED, BUT THE CONTENT OF THE ARCHIVED FILES (SINGLE IMAGE DATA) WAS SAVED PARTIALLY DEFECTIVE. ON THE PART OF SYNGO IMAGING THERE IS A MECHANISM TO CHECK IF DATA WHICH WAS SENT TO EMC LONG TERM ARCHIVE WAS SAFED EFFECTIVELY. CERTAINLY THIS CHECK DOES NOT CONSIDER THAT THE CONTACT OF THE SAVED DATA IS CORRECT BUT IF THE FILE SENT IS PRESENT IN THE EMC FILE SYSTEM. THIS EXPANDED CHECK TO CHECK ALSO THE CONTENT OF THE FILES WAS INTRODUCED SINCE (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNGO IMAGING SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ SIEMENS AG 10014063 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other