BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV REPORTING

    MDR report key: 6200934 · Received December 22, 2016

    Report

    Report Number
    1225058-2016-00001
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    April 18, 2016
    Report Date
    December 22, 2016
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING THIS MDR REPORTABLE EVENT ON DECEMBER 22, 2016. ON NOVEMBER 22, 2016, THE CUSTOMER REPORTED TO AGFA THAT WHEN USING MPAX CV REPORTING FOR NON-INVASIVE VASCULAR ULTRASOUND (NIV), WHEN BUILDING A NIV REPORT, IN THE CONCLUSION SECTION OF THE UPPER ARTERIAL DUPLEX, IF YOU SELECT ANY CHECK BOXES UNDER THE LEFT ANEURYSM IT PUTS IN THE REPORT THAT THERE WAS NO ANEURYSM. THIS REPORT IS FOR THE 1ST OF THREE EVENTS FOR THE SAME ISSUE AT THIS SITE. ON NOVEMBER 22, 2016, AGFA TECHNICAL SUPPORT CONTACTED THE CUSTOMER AND UPDATED HIM THAT ONLY THREE (3) REPORTS WERE AFFECTED AND THOSE THREE (3) REPORTS WERE ALL LISTED AS TEST REPORTS. THE CUSTOMER WAS PROVIDED THE LIST OF THE AFFECTED REPORTS. AGFA TECHNICAL SUPPORT RE-CONFIGURED THE REPORTS TO PRODUCE CORRECT STATEMENTS IN BOTH THE TEST AND PRODUCTION ENVIRONMENT. A PROBLEM RECORD WAS CREATED ON NOVEMBER 23, 2016 TO ADDRESS THE ISSUE VIA PROBLEM RECORD NUMBER (B)(6). ON DECEMBER 22, 2016 AGFA HAS IMPLEMENTED A CORRECTION VIA AGFA ID - (B)(4) (1225058-12-22-2016-001-C). AGFA SENT URGENT SAFETY NOTICES TO AFFECTED CONSIGNEES FOR THIS ISSUE DESCRIBED IN (B)(4) (1225058-12-22-2016-001-C) ON DECEMBER 22, 2016. THE LETTER INFORMED THE CONSIGNEES THAT AGFA SERVICES WILL CONTACT THE AFFECTED CONSIGNEES TO: EXECUTE A QUERY TO FIND ALL AFFECTED REPORTS AT THE AND TO PROVIDE THE RESULTS. THE QUERY WILL NOT REQUIRE DOWNTIME AND WILL NOT IMPACT SYSTEM PERFORMANCE. CORRECT THE NIV REPORTING CLINICAL CONTENT. THE CORRECTION ACTIVITY WILL NOT REQUIRE DOWNTIME. THE LETTER ALSO INFORMED CUSTOMERS TO CONTACT AGFA IF THEY HAD ANY QUESTIONS RELATED TO THE COMMUNICATION LETTER. A MANDATORY SERVICE BULLETIN WILL BE RELEASED TO PROVIDE DOCUMENTATION ON HOW TO DEPLOY THE CORRECTION FOR THIS ISSUE WITH IMPAX CV REPORTING. ANY ADDITIONAL REPORTING FOR THIS CORRECTION ACTIVITY WILL BE REPORTED TO FDA VIA 21 CFR 806 REPORTING VIA AGFA ID - (B)(4) (1225058-12-22-2016-001-C). 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) 2016, WHEN THE ERROR OCCURRED. REPORT ID DATE ERROR OCCURRED: (B)(4) (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849860 IMPAX CV REPORTING CV REPORTING LLZ AGFA HEALTHCARE CORP. IMPAX CV12

    Patients

    Seq Age Sex Outcome Treatment
    1