BEUDAMED
    FDA Adverse Event Other Summary report: N

    AGFA HEARTLAB CVS RESUTLS MANAGER OUTBOUND

    MDR report key: 1003068 · Received February 22, 2008

    Report

    Report Number
    1063474-2008-00001
    Event Type
    Other
    Date Received
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    HEARTLAB, AN AGFA HEALTHCARE NV COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Removal / Correction Number
    1063474-2/22/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO REPORTS OF ACTUAL HARM TO PATIENTS. THE PRODUCT GENERATES A REPORT, WHICH IS THEN AVAILABLE: CO SYSTEMS ARE PRESENTLY NOT CLASSIFIED AS MEDICAL DEVICES. HOWEVER, ANY TIME THERE IS DATA DISCREPANCY, WITH CLINICAL CONTENT ELEMENTS BEING UNAVAILABLE TO THE END-USER, THERE IS SOME POTENTIAL FOR HARM. IN THIS PARTICULAR CIRCUMSTANCE, DEALING SOLELY WITH THE NUCLEAR CARDIOLOGY REPORT MANAGER, THE DATA ELEMENTS INVOLVED ARE CERTAINLY NOT THE SOLE DETERMINANTS FOR CLINICAL DECISION MAKING, SO THE POTENTIAL FOR HARM IS LOW. HOWEVER, IF THE SITUATION WERE TO RECUR, WITH MORE CLINICALLY SIGNIFICANT DATA ELEMENTS BEING UNAVAILABLE FOR CLINICAL REVIEW, THE CLINICAL END-USER OF THE CO REPORT MIGHT MAKE CLINICAL DECISIONS THAT COULD CONTRIBUTE TO SERIOUS INJURY. COMPLICATING THE ISSUE IS THAT THE CO REPORT IS PRESENTED IN THE CO TO A WIDE VARIETY OF USERS, SOME OF WHICH ARE NOT WELL VERSED IN THE FIELD OF CARDIOLOGY (E.G. EMERGENCY DEPARTMENT PHYSICIANS). FOR EXAMPLE, IF THE "CONCLUSIONS" SECTION IS NOT AVAILABLE IN THE HIS REPORT, THE FINAL RECOMMENDATIONS WOULD NOT BE AVAILABLE FOR AN END-USER WHO IS NOT EXPERT WITH THE MORE TECHNICAL ELEMENTS OF A CARDIOLOGY STUDY. THIS COULD PROMPT A REPEAT DIAGNOSTIC STUDY, WITH ATTENDANT RISKS (E.G. ADMINISTRATION OF CONTRAST MATERIAL, CAUSING ALLERGIC REACTION OR RENAL FAILURE). AGFA IS BEING CONSERVATIVE IN REPORTING THIS PRODUCT PROBLEM.

    Description of Event or Problem · 1

    PRODUCT UTILIZES SOFTWARE, CALLED "REPORT MANAGER FOR NUCLEAR REPORTING, OUTBOUND REPORT, VERSION 2.04.20. THIS SOFTWARE GENERATES A REPORT TO BE SENT TO THE INFORMATION SYSTEM. THIS REPORT IS REFERRED TO AS THE "OUTBOUND" REPORT AND IS COMMONLY RETRIEVED FROM A SITES HIS FOR USE IN PATIENT CARE. IN LATE 2007, AGFA WAS CONTACTED BY A USER THAT INFORMATION AVAILABLE FROM THE PRODUCT, AND PRESENT IN A SEPARATE REPORT (ALSO GENERATED BY REPORT MANAGER AND STORED ON THE PRODUCT) WAS NOT PRESENT IN THE "OUTBOUND" REPORT. AN EVALUATION BY AGFA PERSONNEL OF THE REQUEST FROM THIS USER FOR THE ADDITIONAL INFORMATION DETERMINED THAT BASED ON THE POTENTIAL USE OF THE "OUTBOUND" REPORT BY HOSPITAL PERSONNEL, CRITICAL AVAILABLE DATA SHOULD HAVE BEEN INCLUDED IN THE DESIGN OF THE "OUTBOUND" REPORT. RISK ANALYSIS CONDUCTED BY AGFA PERSONNEL SUGGESTED THERE IS A POTENTIAL RISK OF SERIOUS INJURY, DUE TO POSSIBLE TREATMENT DECISIONS BECAUSE OF LACK OF KNOWN INFORMATION IN THIS REPORT. INFORMATION NOT INCLUDED IN THE "OUTBOUND" REPORT IS THE HEMODYNAMICS TABLE, AND THE CONCLUSIONS FROM THE NUCLEAR DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGFA HEARTLAB CVS RESUTLS MANAGER OUTBOUND PICTURE ARCHIVING COMMUNICATION SYSTEM LLZ HEARTLAB, AN AGFA HEALTHCARE NV COMPANY OUTBOUND REPORT SW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other