BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    MDR report key: 3403666 · Received September 17, 2013

    Report

    Report Number
    1225058-2013-00935
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    May 9, 2012
    Report Date
    November 4, 2014
    Manufacturer
    AGFA HEALTHCARE CORP
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Removal / Correction Number
    Z-2112-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED 510K # FROM K050858 TO K050228 ADDED PRODUCT CODE : LLZ -

    Description of Event or Problem · 1

    AGFA SUBMITTED MDR REPORT # 1225058-2013-00001 TO THE FDA ON (B)(4) 2010 FOR A CUSTOMER IN THE U.S.A AND OCCURRENCE IS BEING REPORTED FOR THE SAME ISSUE/SAME DEVICE: IMPAX CV RESULTS MANAGEMENT ADMINISTRATION TOOL (RMAT), BUT WITH A CUSTOMER IN (B)(6). IN (B)(6) 2012, THE (B)(6) CUSTOMER REPORTED TO AGFA THAT SOME FIELDS FOR CUSTOM FINDING "MORPHOLOGY" UNDER "AORTIC VALVE" WERE NOT BEING SAVED. SPECIFICALLY, THE FOLLOWING REPORT OPTIONS: "TRANSESOPHOGEAL ECHO (TEE) REPORT --> AORTIC VALVE --> MORPHOLOGY: WHEN CHOOSING "YES" FOR RHEUMATIC VALUE, AND "PROBABLE RHEUMATIC AV'" FOR PROBABILITY RHEUMATIC, AND "COMMISSURAL FUSION, IN ROLLING.. (INCOMPLETE)... FOR RHEUMATIC MORPHOLOGY, THEN WHEN CLICKING ON SHOW REPORT, NONE OF THESE GET UPDATED ON THE TEE REPORT. WHEN CLICKING ON THE AORTIC VALVE AGAIN, ALL THE CHOSEN VALUES DISAPPEAR. IN (B)(6) 2012, AN AGFA CARDIO CLINICAL REPORTING SPECIALIST DETERMINED THE SITE USERS WERE SELECTING SPECIFIC PORTIONS OF COMPOUND SENTENCES WHEN CREATING A CARDIOVASCULAR REPORT, BUT WHEN REVIEWED, THE USER REALIZED THOSE SPECIFIC COMPOUND SENTENCES WERE NOT POPULATING IN THE CARDIOVASCULAR REPORT. THE CAUSE OF THE ISSUE WAS DUE TO A COMPOUND SENTENCE THAT WASN'T CONFIGURED CORRECTLY. AGFA DOES NOT SUPPORT COMPOUND STATEMENTS IN TEE AND COULD NOT MAKE ANY CHANGES TO ANY OF THE COMPOUND STATEMENTS. AGFA RECOMMENDED THE SITE TURN OFF THE COMPOUND STATEMENT FOR RHEUMATIC AORTIC VALVE BY CHANGING THE GUI TYPES FROM THE COMPOUND FEATURE TO THE RADIO FEATURE. THE COMPOUND SENTENCE WAS DISABLED. NO REPORTS WERE AFFECTED DUE TO THIS EVENT AND NO HARM TO PTS HAS BEEN REPORTED. A REPORTABLE CORRECTION IS UNDERWAY FOR THIS ISSUE AND HAS BEEN REPORTED TO THE FDA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467406 IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08) PICTURE ARCHIVING AND COMMUNICATION LLZ AGFA HEALTHCARE CORP RM 2.08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1