BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3143445 · Received June 3, 2013

    Report

    Report Number
    1225058-2013-00195
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 24, 2013
    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
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS IS THE 15TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON/CARDIO PURGE SERVICE. THIS EVENT WAS REPORTED BY THE CUSTOMER TO AGFA ON (B)(6) 2013 FOR HOTEL (B)(6). THE USER REPORTED TO AGFA THAT THE SITE COULD NOT SEE IMAGES ON HEARTLAB. THE CUSTOMER WAS UNABLE TO VIEW IMAGES FROM ANY CARDIO REVIEW STATIONS (CRS). HOWEVER, THE CUSTOMER WAS ABLE TO VIEW IMAGES VIA THE WEB CLIENT AS WELL AS ON THE MODALITY. AGFA SERVICE IDENTIFIED THERE WERE TWO IMAGE LOCATIONS THAT DO NOT PURGE DUE TO MIXED IMAGE STATUS TYPES. DICOMSTORE WAS CORRECTLY CONFIGURED BY AGFA SERVICE AND SERVICE WAS RESTORED IN LESS THAN AN HOUR. ALL IMAGES WERE AVAILABLE FOR VIEWING AFTER THE CONFIGURATION WAS RESTORED. THERE WAS NO REPORT OF PATIENT HARM OR 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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
    245606 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