BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 2980681 · Received February 27, 2013

    Report

    Report Number
    1225058-2013-00186
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT # 1225058-2012-00003 TO THE FDA ON (B)(4) 2012. THIS IS THE 9TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON. ON (B)(6) 2013, A AGFA ZONE SUPPORT SPECIALIST WITH PROFESSIONAL SERVICES, WHILE PERFORMING AN INSTALL FOR CARDIO PURGE SERVICE (CPS), DETERMINED A WRONG CONFIGURATION OF DICOMSTORE IN COMBINATION WITH MEDIA PURGE DAEMON (MPD). THE SITE ONCE HAD MPD, BUT IT WAS NOT INSTALLED AT THE TIME OF THE EVENT. THE ROOT CAUSE WAS WRONG CONFIGURATION YET THE CUSTOMER SITE WAS NOT CURRENTLY PURGING DATA. THE CUSTOMER WAS USING DIFFERENT PATHS TO KEEP MULTIPLE IMAGE LOCATIONS FOR ARCHIVE AND THERE WAS NO DATA LOSS. THE CPS UPGRADE IS UNDERWAY AND SCHEDULED TO BE COMPLETE WITHIN WEEK OF (B)(6) 2013. NO HARM TO ANY PATIENTS OCCURRED DURING THIS EVENT. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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)(6) 2008. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84258 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