BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3143337 · Received June 3, 2013

    Report

    Report Number
    1225058-2013-00191
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    June 24, 2012
    Report Date
    June 3, 2013
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS IS THE 11TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON/CARDIO PURGE SERVICE THE EVENT WAS REPORTED TO AGFA ON (B)(6) 2012 BY (B)(6) MEDICAL CENTER. THE USER REPORTED TO AGFA THAT ¿CATH LAB IMAGES WERE GOING TO THE WEB SERVER BUT THE IMAGES WERE NOT MAKING IT TO THE READING STATION.¿ THE IMAGES WERE AVAILABLE FOR VIEWING ON THE WEB CLIENT BUT NOT THE CRS. AGFA TECHNICAL INVESTIGATION REVEALED THE IMAGES WERE SUCCESSFULLY SENT TO THE SERVER NAME ¿(B)(6)¿ BUT WERE NOT BEING INDEXED TO THE DATABASE BECAUSE OF DICOMSTORE MISCONFIGURATION. AGFA RE-CONFIGURED DICOMSTORE AND THE SITE WAS ABLE TO VIEW IMAGES FROM THE WEB CLIENT WITHOUT ISSUE. THERE IS NO REPORTED DELAY OR IMPACT TO PATIENT CARE. THERE WAS NO KNOWN DATA LOSS. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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 JUNE 2008. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # IS Z-2252-2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244483 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