BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV REPORTING

    MDR report key: 3001059 · Received February 26, 2013

    Report

    Report Number
    1225058-2013-00128
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 26, 2013
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SOFTWARE VERSION USED IS: VERSION: 2.4.67.00.SU2, RELEASE DATE: 2010-02-06 (ALSO CALLED CV 734 SU3). EVALUATION SUMMARY: AGFA'S INVESTIGATION OF THIS MDR REVEALED THAT IN 2012 A CORRECTION WAS IMPLEMENTED BY AN AGFA CLINICAL ANALYST BY RECONFIGURING THE CUSTOMER'S SYSTEM TO ELIMINATE THE TYPE OF MISMAPPING SEEN IN THIS CURRENT MDR. (THE 2012 EVENT AND CORRECTION WERE REPORTED VIA FDA MDR 1225058-2012-00002). THIS PAST CORRECTION WAS MISTAKENLY REVERTED TO IT'S PREVIOUS CONFIGURATION IN IMPAX CV FOR PHILIPS IE-33 ULTRASOUND CARTS BY AN AGFA PROFESSIONAL SERVICES PERSON, THUS RE-ENABLING THE ERRORS INITIALLY FOUND ON (B)(6) 2012. ON (B)(4) 2013, AGFA CORRECTED THE ISSUE BY RECONFIGURING THE CUSTOMER'S SYSTEM AND ELIMINATING THE MISMAPPING. THE CUSTOMER HAS CONFIRMED THE IMPLEMENTED CORRECTION HAS FIXED THE PROBLEM AND THERE ARE NO FURTHER ISSUES. NO REPORTS OF PT HARM WERE REPORTED DURING THIS EVENT. DURING THE INVESTIGATION IT WAS DISCOVERED 185 STUDY DATES WERE IMPACTED AND INCLUDED 1415 MRNS (MEDICAL RECORD NUMBERS). AGFA WILL SUBMIT A MDR TO THE FDA FOR EACH OF THE 185 STUDY DATES AND INCLUDE THE SPECIFIC MRNS REFERENCING EACH STUDY DATE. THE MDR SUBMISSION NAMES FOR THE ENTIRE EVENT WILL INCLUDE: 1225058-2013-00001 THROUGH 1225058-2013-00185. STUDY DATE: (B)(6) 2012. MRNS: (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A LEAD ECHO SONOGRAPHER ALERTED AGFA THAT ULTRASOUND MEASUREMENTS WERE INSERTED IN THE WRONG LOCATION FOR 2 DIFFERENT PHILLIPS IE33 ULTRASOUND CARTS. THE CARDIOLOGIST WAS CONCERNED THAT ERRONEOUS MEASUREMENTS RESULTED IN INCORRECT DIAGNOSIS AS THE MITRAL REGURGITATION IS RATED HIGHER THAN IT ACTUALLY IS. ADDITIONALLY, THE SPECIFIC MEASUREMENT VALUES WERE NOT CONSISTENT WITH THE ACQUIRED IMAGE STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81484 IMPAX CV REPORTING IMPAX CV REPORTING LLZ AGFA HEALTHCARE CORP. IMPAX CV 7.4SU3 HF1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1