IMPAX CV DISCOMSTORE 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 8TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE, BUT WITH A DIFFERENT CUSTOMER. ON (B)(4) 2012, A AGFA SVC ENGINEER, WHILE PERFORMING A DIFFERENT SVC AT THE CUSTOMER SITE, DISCOVERED THE SITE'S DICOMSTORE WAS MISCONFIGURED, WHICH LED TO MIXED IMAGE STORAGE LOCATIONS. TO MITIGATE THE POTENTIAL FOR DATA LOSS, AGFA SVC HAS APPLIED CONFIGURATION CHANGES TO THE CUSTOMER'S DATABASE TO ADDRESS THE MIXED STORAGE LOCATION ISSUE. THIS ISSUE WAS IDENTIFIED BY AGFA SVC AND NO HARM TO ANY PTS OCCURRED DURING THIS EVENT.

Additional Manufacturer Narrative

MEDIA PURGE DAEMON (MPD) IS AN OLDEN AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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 SVC (CPS) IN (B)(4) 2008. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. FDA REFERENCE # IS Z-2252-2012.