BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3143270 · Received June 3, 2013

    Report

    Report Number
    1225058-2013-00190
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 15, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS IS THE 10TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON/CARDIO PURGE SERVICE (CPS) THIS OCCURRENCE WAS REPORTED TO AGFA ON (B)(6) 2011 FROM (B)(6) HOSPITAL. THE USER REPORTED TO AGFA THAT CPS WAS NOT PURGING STUDIES. THE SITE¿S BACKUP DATABASE WAS AT CAPACITY AND IMAGES WERE NOT BEING STORED PROPERLY IN THEIR RESPECTIVE ARCHIVE LOCATIONS. AGFA'S TECHNICAL INVESTIGATION REVEALED MISCONFIGURATION AS A SHARED SERVER WAS DIRECTED TO STORE BOTH OL AND O2 IMAGES. CPS HAD BEEN PURGING THIS STORAGE LOCATION. HOWEVER, THE SECONDARY STORAGE LOCATION WAS CONFIGURED PROPERLY AND CPS WAS NOT PURGING THIS LOCATION. THERE IS NO KNOWN DATA LOSS. CPS AND DICOMSTORE WERE RECONFIGURED CORRECTLY BY AGFA. THERE HAS BEEN NO REPORTED PATIENT HARM DUE TO THIS EVENT. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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
    244081 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