BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 2568037 · Received May 1, 2012

    Report

    Report Number
    8022257-2012-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    January 24, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY HAS DETERMINED THAT THE ROOT CAUSE OF THE PROBLEM IS THAT SOME RADIOLOGY RESIDENTS AT THE JEWISH GENERAL HOSP INAPPROPRIATELY INVOKED THE "SAVE FINAL" BUTTON INSTEAD OF THE "SAVE PRELIMINARY" BUTTON. BOTH THE "SAVE FINAL" AND "SAVE PRELIMINARY" BUTTONS WERE ENABLED FOR THE RADIOLOGY RESIDENTS' ROLE DUE TO A SOFTWARE DEFECT, WHEN ONLY THE "SAVE PRELIMINARY" BUTTON SHOULD HAVE BEEN ENABLED. CONSISTENT WITH THE COMMON PRACTICE AT TEACHING HOSPITALS AND THE WORKFLOW PRESENTED IN THE DEVICE'S USER GUIDES, THE "SAVE FINAL" BUTTON IS INTENDED TO BE USED BY ACCREDITED RADIOLOGISTS WHO OVERREAD THE PRELIMINARY REPORTS CREATED BY THE RADIOLOGY RESIDENTS. IF A RADIOLOGY RESIDENT MAKES A GROSS MISDIAGNOSIS IN THEIR PRELIMINARY REPORT AND CLICKS "SAVE FINAL", IT WILL NOT BE OVERREAD BY AN ACCREDITED RADIOLOGIST AND COULD LEAD TO SIGNIFICANT HARM TO THE PT. MCKESSON MEDICAL IMAGING COMPANY CUSTOMER SUPPORT WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A TECHNICAL SOLUTION TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, A CUSTOMER REPORTED THAT TWO RADIOLOGY RESIDENTS WERE ABLE TO SAVE A PRELIMINARY REPORT AS A FINAL REPORT ALTHOUGH THEY DID NOT HAVE AUTHORIZED PERMISSIONS TO DO SO. OVER THE COURSE OF A MONTH, INVESTIGATION OF THE PROBLEM CONTINUED BUT NO OTHER OCCURRENCES WERE IDENTIFIED. HOWEVER, MONITORING CONTINUED. ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THE PROBLEM RECURRED. THERE WAS NO HARM TO PATIENTS REPORTED IN BOTH COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMMUNICATION SYS LLZ MCKESSON MEDICAL IMAGING COMPANY 11.6

    Patients

    Seq Age Sex Outcome Treatment
    1