BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)

    MDR report key: 3143412 · Received June 3, 2013

    Report

    Report Number
    1225058-2013-00193
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    December 2, 2014
    Report Date
    October 20, 2015
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS TO REPORT MANDATORY CORRECTIVE ACTIONS THAT HAVE BEEN TAKEN AT THE SITE THROUGH MANDATORY SERVICE BULLETIN DIS031.14E VIA REPORTABLE CORRECTION Z-2252-12. THIS MANDATORY SERVICE BULLETIN DIS031.14E PROVIDED A HOTFIX FOR CARDIO PURGE SERVICE (CPS) TO MITIGATE THE RISK FO FUTURE DATA LOSS.

    Description of Event or Problem · 1

    (B)(4). THIS IS THE 13TH OCCURRENCE BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON/ CARDIO PURGE SERVICE. AN INTERNAL FINDING DURING AN AGFA PROACTIVE CHECK DISCOVERED THIS EVENT. AN AGFA SERVICE ENGINEER REPORTED THE DICOMSTORE MISCONFIGURATION FOR (B)(6) HOSPITAL. THIS SITE CURRENTLY DOES NOT PURGE AND THERE HAS NOT BEEN ANY DATA LOSS IDENTIFIED AS OF (B)(6) 2013. THERE HAS BEEN NO HARM TO PATIENTS. THE CUSTOMER IS FULLY FUNCTIONAL AND IS NOT CURRENTLY EXPERIENCING ANY ISSUES WITH PRIOR STUDIES. ONCE THE CORRECTION HAS BEEN DETERMINED AND IMPLEMENTED AT THE SITE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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PURGE DAEMON (MPD) IS AN OLDER AGFA PRODUCT USED TO PURGE THE IMAGES STORED ON THE PRIMARY MEMORY CACHE ONCE THEY HAVE BEEN ARCHIVED TO A LONG TERM ARCHIVE AND THE AMOUNT OF DATA STORED ON-LINE REACHES A PREDEFINED AMOUNT.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
    243940 IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD) 2. COMMON DEVICE NAME MEDICAL IMAGE STORAGE DEVICE LLZ AGFA HEALTHCARE CORP. IMPAX CV DICOMSTORE ALL VERSIONS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1