BEUDAMED
    FDA Adverse Event Summary report: N

    PICOM

    MDR report key: 2861394 · Received November 30, 2012

    Report

    Report Number
    MW5027956
    Date Received
    November 30, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SCIMAGE INC
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NEAR MISS ON PT MIS IDENTIFICATION/INCORRECT REPORT WHEN DR (B)(6) OPENED CASE (B)(6), THE REPORT PANE LOADED, WITH THE CORRECT PT INFO, THE PRIOR REPORTS PANE OPENED WITH THE CORRECT PT INFO. HOWEVER THE IMAGES WERE DISPLAYING ON THE VIEWER WERE THAT OF CARE (B)(6). (B)(6) HAD PREVIOUSLY BEEN READ BY DR (B)(6), AND AS FAR AS I CAN TELL, IT WAS THE LAST CASE HE HAD READ, LOOKING AT THE AUDIT LOGS AND CHECKING THE DELIVERED TIMES OF TODAYS CASES. THE ISSUE BEING THAT HE WAS ABLE TO INDICATE INTO THE REPORT ON CASE (B)(6) BUT ALL WHILE SEEING THE IMAGES OF CASE (B)(6) DR (B)(6) TAG DOES NOT SHOW UP ON CASE (B)(6) AUDIT LOG, EVEN THOUGH THE REPORT PANE AND PRIOR REPORT FULLY LOADED FOR HIM. THE AUDIT LOG SHOWS DR. B TAKING THE CASE, BUT DOES NOT MENTION DR (B)(6) ON CASE (B)(6). PLEASE INVESTIGATE WHY THE AUDIT LOG DOESN'T SHOW DR (B)(6) AND WHY THE IMAGES DID NOT MATCH THE LOADED REPORT. IMAGE VIEWER WAS MISMATCHED WITH ACTIVE PT IN REPORT PANE. ADDITIONALLY, SYSTEM DID NOT APPROPRIATELY LOG VIEWING WHICH IS AN AUDITABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICOM POWER CONSOLE LLZ SCIMAGE INC POWERCONSOLE 5.24

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PICOM POWERCONSOLE PACS VIEWER