BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV12

    MDR report key: 5045583 · Received September 1, 2015

    Report

    Report Number
    1225058-2015-14123
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 17, 2015
    Report Date
    September 1, 2015
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS CORRECTED FROM (B)(6) 2015 TO (B)(6) 2015.

    Description of Event or Problem · 1

    WE ARE REPORTING THIS SUPPLEMENTAL REPORT ON OCTOBER 11, 2016. AFTER AN FDA INSPECTION, CONDUCTED AT ONE OF OUR AGFA SITES, AND THE INSPECTION CLOSED ON (B)(6) 2016, WE REALIZED THE DATE OF EVENT FOR THIS MDR 1225058-2015-14123 WAS INCORRECT. THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE THE CORRECTION FOR THE DATE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO AGFA ON (B)(6) 2015 THAT THE DEMOGRAPHICS MANAGER (VERSION 12.0.1-BUILD-03) CAUSED REPORT DATA MISATTRIBUTION. SEVERAL RESULT PDFS DID NOT CROSS TO THE CUSTOMER'S HIS, MEDITECH. ROOT CAUSE AS A PRODUCT DEFECT WITHIN THE DEMOGRAPHICS MANAGER COMPONENT OF IMPAX CV. HOWEVER, THE PATIENT DEMOGRAPHIC DATA MAY CHANGE AFTER THE REPORT IS SIGNED AND THIS NEW INFORMATION SHOULD BE REFLECTED IN THOSE PREVIOUSLY-SIGNED SYSTEM REPORTS. THE DEMOGRAPHICS MANAGER UPDATES PREVIOUSLY SIGNED REPORTS (XML AND PDF FILES) WITH THE REVISED PATIENT DEMOGRAPHICS INFORMATION AND RESENDS THE INFORMATION TO THE PROPER EXTERNAL SYSTEMS. THE DEMOGRAPHICS MANAGER IS ABLE TO REVISE THE REPORTS WITHOUT HAVING PHYSICIANS RE-SIGN THEIR PREVIOUSLY SIGNED REPORTS. THE DEMOGRAPHICS MANAGER SERVICE WILL ALWAYS REGENERATE THE PDFS OF ALL SIGNED REPORTS FOR A PATIENT AND/OR STUDY. THE ARCHIVE VERSIONS OF THE REPORT ARE THE TWO COPIES OF XML FILES LOCATED ON THE REPORT STORAGE SERVER AND THE BACKUP SERVER. A PRODUCT DEFECT IN THE DEMOGRAPHICS MANAGER CODE MAY CAUSE SOME REPORTING OBJECTS TO BE POPULATED WITH ANOTHER REPORT'S DATA CAUSING MISATTRIBUTION. UNDER NORMAL CONFIGURATION/OPERATION, THE DM SERVICE FINISHES THE DEMOGRAPHIC UPDATES WITHIN A 120 SECOND WINDOW. IF HOWEVER A LARGE NUMBER OF JOBS ARE QUEUED UP AND THEY DO NOT FINISH PROCESSING WITHIN THE 120 SECOND WINDOW, MISATTRIBUTION MAY OCCUR. ON (B)(6) 2015, AGFA HAS IMPLEMENTED A CORRECTION VIA AGFA ID (B)(4). MANDATORY SERVICE BULLETINS HAVE BEEN RELEASED TO PROVIDE DOCUMENTATION ON HOW TO DEPLOY THE CORRECTION FOR DEMOGRAPHICS MANAGER (DM) FOR SITES WITH IMPAX CV 7.8.X AND CV12 12.2.SU1 AND SU2 INSTALLED. THERE HAVE BEEN NO REPORTS OF PHYSICAL HARM OR HEALTH DAMAGE RESULTING FROM THIS ISSUE. THIS MEDICAL DEVICE REPORT INCLUDES 1 REPORT AFFECTED ON (B)(6) 2015, WHEN THE ERROR OCCURRED. REPORT ID: (B)(4), DATE ERROR OCCURRED: 08/17/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579730 IMPAX CV12 IMPAX CARDIOVASCULAR (CV12) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP. IMPAX CV12 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1