IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON

Description of Event or Problem

AGFA SUBMITTED MDR REPORT # 1225058-2012-00003 TO THE FDA ON (B)(4) 2012. THIS IS THE (B)(4) OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE, BUT WITH A DIFFERENT CUSTOMER. THIS EVENT OCCURRED IN GREAT BRITAIN. AN AGFA ENGINEER WAS IN THE PROCESS OF PERFORMING A SOFTWARE UPGRADE FROM MEDIA PURGE DAEMON (MPD) TO CARDIO MISCONFIGURATION. THIS ISSUE WAS IDENTIFIED BY AGFA SERVICE AND NO HARM TO ANY PTS OCCURRED DURING THIS EVENT. THIS MISCONFIGURATION ALLOWED IMAGES FROM DIFFERENT ONLINE STORAGE (OL AND O2) LOCATIONS TO BE INDEXED INTO THE SAME STORAGE LOCATION (ALSO DEFINED AS CROSS LOCATION), WHICH WAS PURGED BY MPD. THE CROSS LOCATION COMBINED IMAGES FROM TWO DIFFERENT HOSPITALS IN THE SAME STORAGE LOCATION. AS PART OF THE INVESTIGATION, THE IMAGES MUST BE SORTED AND ASSOCIATED WITH THE APPROPRIATE SOURCE HOSPITAL. PRELIMINARY INVESTIGATION SHOWS THE TWO HOSPITALS INVOLVED DO NOT HAVE LONG-TERM ARCHIVAL SOLUTIONS. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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)(4) 2008. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE ASSESSMENT FOR RECOVERING IMAGES IS COMPLETED.