BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON

    MDR report key: 2590506 · Received May 24, 2012

    Report

    Report Number
    1225058-2012-00010
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 24, 2012
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LMB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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 SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE ASSESSMENT FOR RECOVERING IMAGES IS COMPLETED.

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT NUMBER: 1225058-2012-00003 TO THE FDA ON (B)(6) 2012 AND A 2ND OCCURRENCE FOR THE SAME ISSUE/SAME DEVICE, WAS REPORTED ON (B)(6) 2012. A 3RD EVENT WITH THE SAME CUSTOMER/ISSUE/DEVICE OCCURRED (B)(6) 2012. THE CUSTOMER ATTEMPTED TO ACCESS A STUDY FROM (B)(6) 2010 AND MAKE A COPY OF THE ECHO IMAGES FOR COMPARISON. AN ERROR RESULTED IN FAILURE TO PRODUCE THE IMAGES. THE IMAGES HAD BEEN PURGED, AS WERE THE PREVIOUS MDR REPORTED IMAGES, AND CANNOT BE BURNED TO A CD/DVD, BUT ARE AVAILABLE ON THE WEB. THE CUSTOMER INDICATES THERE WAS NO PT HARM ASSOCIATED WITH THIS 3RD OCCURRENCE. AGFA HAD ALREADY PERFORMED AN INVESTIGATION AND REVEALED THE SITE HAD TWO SANS (STORAGE ARE NETWORK) USED TO STORE IMAGE DATA ON BOTH SANS AT THE SAME TIME AND ONE RIMAGE CD BURNER USED TO ARCHIVE IMAGES ON DVDS. THE CONFIGURATION OF THE SYSTEM HAD BEEN MODIFIED TO USE THE 2ND SAN FOR ADD¿L STORAGE, BUT THIS WAS NOT A SUPPORTED CONFIGURATION. DICOMSTORE CONFIGURATION WAS ALSO NOT ADEQUATE, AS ALL DIFFERENT TYPES OF IMAGES (ONLINE/WEB IMAGES) WERE STORED IN THE SAME FOLDERS. WHEN THE TWO SANS FOLDERS BECAME FULL, TO GAIN STORAGE SPACE, MEDIA PURGE DAEMON (MPD) AUTOMATICALLY STARTED TO DELETE THE OLDEST WEB IMAGES. HOWEVER, MPD DID NOT RECOGNIZE THAT SOME OF THE IMAGES STORED IN THE SAME FOLDER AS THE WEB IMAGES WERE ACTUALLY ORIGINAL RECOGNIZE THAT SOME OF THE IMAGES STORED IN THE SAME FOLDER AS THE WEB IMAGES WERE ACTUALLY ORIGINAL DICOM IMAGES AND IT DELETED ALL FILES CONTAINED IN THESE FOLDERS. AGFA DETERMINED WRONG CONFIGURATION OF DICOMSTORE IN COMBINATION WITH MEDIA PURGE DAEMON IS THE ROOT CAUSE OF THIS EVENT. MPD HAS BEEN DEACTIVATED AT THE SITE AND WILL BE REPLACED BY IPAX CV CARDIO PURGE SERVICE. DICOMSTORE CONFIGURATION HAS BEEN MODIFIED AT THE SITE TO ENSURE THAT THE ORIGINAL DICOM IMAGES AND WEB (JPEG VERSIONS) IMAGES ARE STORED ON DIFFERENT HARD DRIVES. RECOVERY OF IMAGES IS CURRENTLY UNDERWAY BY AGFA ENGINEERS. AGFA SENT A CERTIFIED LETTER TO THE SITE ADVISING THEM TO PURCHASE ADD¿L STORAGE AND TO CORRECTLY ARCHIVE IMAGES USING THE RIMAGE CD BURNER, SO THAT RECOVERY OF IMAGES CAN CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON MEDICAL IMAGE STORAGE DEVICE LMB AGFA HEALTHCARE CORP. ALL VERSIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA