BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3833832 · Received May 27, 2014

    Report

    Report Number
    1225058-2014-00264
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Removal / Correction Number
    Z-2252-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AGFA'S AWARENESS DATE IS (B)(4) 2014 FOR THIS EVENT. AGFA SUBMITTED AN INITIAL MDR REPORT # 1225058-2012-00003 TO THE FDA DESCRIBING THIS ISSUE. THIS IS THE 24TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON/CARDIO PURGE SERVICE, BUT WITH A DIFFERENT SITE. ON (B)(4) 2014, THE SITE CONTACTED AGFA AND FILED A COMPLAINT FOR AN ISSUE RELATED TO IMAGE STORAGE AND CONFIGURATIONS. DURING THE INVESTIGATION OF THE CUSTOMER COMPLAINT, AGFA DETERMINED THIS NEW OCCURRENCE RELATED TO IMPAX CV DICOMSTORE MIS-CONFIGURATION, HAD OCCURRED. THE DICOMSTORE VERSION THAT WAS IN USE AT THE CUSTOMER SITE WAS CV7.8. MULTIPLE DICOMSTORES ON THE SITE'S "ISCVSWE3" WERE FOUND TO BE RUNNING UNDER MULTIPLE RDP AND CONSOLE SESSIONS, IN WHICH BOTH SESSIONS HAD DICOMSTORE EXECUTABLES, RESULTING IN SOME IMAGES TO INDEX INTO THE DATABASE BUT THE FILE NEVER MADE IT TO THE FILE SYSTEM. THERE WAS NO IMPACT TO THE END USER AND NO DATA WAS LOST AS A RESULT OF THIS DICOMSTORE MISCONFIGURATION. THE SITE'S CONFIGURATION WAS CORRECTED ON (B)(4) 2014, THE SAME DAY THE CUSTOMER COMPLAINT WAS FILED. NOTE: MEDIA PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT. MPD ALLOWS THE SYSTEM TO CONTINUOUSLY RECEIVE THE RECENTLY ACQUIRED IMAGES FROM THIRD PARTIES MODALITIES. THIS TOOL WAS DISCONTINUED AND REPLACED BY CARDIO PURGE SERVICE (CPS) IN (B)(4) 2008. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311644 IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD) MEDICAL IMAGE STORAGE DEVICE LLZ AGFA HEALTHCARE CORP. IMPAX CV DICOMSTORE ALL VERSIONS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1