BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3143395 · Received June 3, 2013

    Report

    Report Number
    1225058-2013-00192
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS IS THE 12TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON. AN INTERNAL FINDING WAS DISCOVERED BY AGFA PERSONNEL DURING INSTALLATION OF ADDITIONAL STORAGE DEVICE AT (B)(6) HOSPITAL. THE USER WAS UNAWARE OF THE ISSUE, AS AN AGFA SUPPORT ENGINEER WAS ADDING STORAGE CAPACITY AND MIGRATING THE NECESSARY IMAGES. AGFA SUPPORT ENGINEER DISCOVERED THERE WERE MULTIPLE IMAGE STATUS VALUES FOR A SINGLE DEVICE NAME THAT WAS A RESULT OF MISCONFIGURATION. RECORDS WITH AN IMAGE STATUS VALUE OTHER THAN THE PROPER, INTENDED VALUE FOR THE DEVICE NAME ARE CONSIDERED MISPLACED LOCATIONS. ACCORDING TO THE CUSTOMER THE EVENT DID NOT CAUSE A DELAY IN CARE AND IMAGES HAVE BEEN READILY AVAILABLE ON THE CRS. THE CUSTOMER IS FULLY FUNCTIONAL AND IS NOT EXPERIENCING ANY ISSUES WITH PRIOR STUDIES. THERE HAS NO DATA LOSS IDENTIFIED AS OF THE DATE OF THIS EVENT NOR ANY HARM TO PATIENTS. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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
    245212 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