BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPAX 6.3 CLIENT SOFTWARE

    MDR report key: 2261514 · Received September 20, 2011

    Report

    Report Number
    2249582-2011-00004
    Event Type
    Death
    Date Received
    September 20, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 19, 2011
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K022292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: NONE OF THE EVAL CODES FIT PARTICULARLY WELL FOR THE "METHOD" HOWEVER, REVIEWING THE VIEWER'S LOGS GAVE US THE BEST INDICATION AS TO WHAT HAPPENED THEREFORE, WE SELECTED CODE (B)(4) FOR USER SURVEY. EVAL: AGFA SERVICE CAREFULLY REVIEWED THE MAP AUDIT EVENT LOGS AND CONFIRMED THAT THERE WAS NO PRODUCT DEFECT. FURTHER INVESTIGATION OF THE INVOLVED AGFA PRODUCTS, AGFA NCONSOLE AND THE IMPAX CLIENT PROVED THE FOLLOWING: WHEN USER MANUAL INSTRUCTIONS ARE FOLLOWED, THE SAFEGUARDS IN THE IMPAX CLIENT AND THE NCONSOLE INTERFACE PREVENT MISTAKES LIKE THIS FROM OCCURRING. THE MAP EVENT TABLE RECORDS SHOWED THAT NEITHER THE PRIOR OR CURRENT STUDY INVOLVED WAS DOUBLE DICTATED. ACCESSION NUMBER (B)(4) WAS DOUBLE REPORTED, MEANING IT COULD ONLY HAVE HAPPENED OUTSIDE OF IMPAX. AS A RESULT OF THE ABOVE, AGFA CAN CONCLUDE THAT THIS PT'S DEATH WAS CAUSED BY THE RADIOLOGIST'S OVERSIGHT, AND CANNOT BE ATTRIBUTED TO ANY PRODUCT DEFECT.

    Description of Event or Problem · 1

    SEQUENCE OF EVENTS: (B)(6). THEN CLICKED ON THE DICTATION BUTTON. THE STUDY INFO WAS TRANSFERRED TO THE POWER SCRIBE DICTATION PRODUCT VIA AGFA NCONSOLE. AT SOME POINT, THE RADIOLOGIST LOOKED AT A PRIOR (ACCESSION NUMBER (B)(4)). THEN STARTED DICTATING 'WHAT HE THOUGHT TO BE THE CURRENT STUDY' WHILE STILL VIEWING THE PRIOR IMAGES. AFTER COMPLETING THE DICTATION HE ELECTRONICALLY SIGNED THE REPORT VIA POWER SCRIBE. ACCORDING TO THE DELAND PACS ADMINISTRATOR AND THE RESULTS OF OUR INVESTIGATION THIS ADVERSE EVENT IS THE RESULT OF A USER ERROR. UPON REVIEW OF THE MAP AUDIT EVENT/LOGS SERVICE HAS CONFIRMED THAT THERE IS NO AGFA PRODUCT DEFECT PRESENT. FURTHER INVESTIGATION OF THE INVOLVED AGFA PRODUCTS, AGFA NCONSOLE AND THE IMPAX CLIENT PROVED THE FOLLOWING: WHEN USER MANUAL INSTRUCTIONS ARE FOLLOWED THE SAFEGUARDS IN THE IMPAX CLIENT AND THE NCONSOLE INTERFACE PREVENT MISTAKES LIKE THIS FROM OCCURRING. THE MAP EVENT TABLE RECORDS SHOWED THAT NEITHER THE PRIOR OR CURRENT STUDY INVOLVED WERE DOUBLE DICTATED. ACCESSION NUMBER (B)(4) WAS DOUBLE REPORTED, MEANING IT COULD ONLY HAVE HAPPENED OUT SIDE OF IMPAX. AS A RESULT OF THE ABOVE, AGFA CAN CONCLUDE THAT THIS PT'S DEATH WAS CAUSED BY THE RADIOLOGIST'S OVERSIGHT, AND CANNOT BE ATTRIBUTED TO ANY PRODUCT DEFECT. TIMELINE: NOTE THAT THE INCIDENT OCCURRED ON (B)(6) 2011. HOWEVER, AGFA ONLY BECAME AWARE OF THE ADVERSE EVENT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX 6.3 CLIENT SOFTWARE PICTURE ARCHIVING AND COMMUNICATIONS SYS LLZ AGFA HEALTHCARE CORP. 6.3.1 SU17 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death