IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON

Additional Manufacturer Narrative

(MEDIA PURGE DAEMON (MDP) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TOP A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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.) THE CUSTOMER SITE WAS STILL USING MPD AT THE TIME OF THIS EVENT. MPD HAS SINCE BEEN DEACTIVATED AT THE SITE AND WILL BE REPLACED BY IMPAX CV CARDIO PURGE SERVICE. AGFA SERVICE HAS RECOVERED THE LOST IMAGES.

Description of Event or Problem

AGFA SUBMITTED MDR REPORT # 1225058-2012-00003 TO THE FDA ON (B)(4) 2012. ON (B)(6) 2012, A DIFFERENT CUSTOMER REPORTED THE SAME ISSUE OF NOT BEING ABLE TO ACCESS OLDER IMAGES FROM THEIR SAN (STORAGE AREA NETWORK). THE CUSTOMER STATED THAT ULTRASOUND IMAGES COULD NOT BE PUSHED FROM THE ULTRASOUND CARTS TO IMPAX CV, AS THE DISKS OF IMPAX CV WERE FULL AND IMAGES FROM YRS 2009 AND 2010 COULD NOT BE ACCESSED ANYMORE. AGFA DETERMINED WRONG CONFIGURATION OF DICOMSTORE IN COMBINATION WITH MEDIA PURGE DAEMON IS THE ROOT CAUSE OF THIS EVENT. THE CUSTOMER CONFIRMED THERE WERE NO REPORTS OF PT HARM, DUE TO THE UNAVAILABILITY OF THE ULTRASOUND IMAGES AS ALL REPORTS OF THE IMAGES WERE AVAILABLE.