BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS SYSTEM

    MDR report key: 5013592 · Received August 19, 2015

    Report

    Report Number
    1125873-2015-00014
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    August 5, 2015
    Report Date
    September 24, 2015
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Removal / Correction Number
    1125873-08-06-15-014-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IDENTIFIES THE RECALL STATUS AND FIELD ACTION NUMBER.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS INVESTIGATED AND ENGINEERING DETERMINED THAT IF ANY TYPE OF ERROR OCCURS (E.G. NETWORK GLITCH, DATA GLITCH, WORKSTATION GLITCH, ETC.) WHILE NAVIGATING TO THE NEXT OR PREVIOUS PATIENT, THEN ECARE MANAGER COULD GET INTO THE STATE WHERE SOME SCREENS WOULD SHOW THE NEW PATIENT WHILE OTHER SCREENS WOULD SHOW THE OLD PATIENT DATA. THIS WOULD IMPACT MORE THAN JUST THE PATIENT REGISTRY SCREEN AND COULD IMPACT ANY SCREEN IN PATIENT CHART. THE PATIENT INFO BAR WOULD SHOW THE PREVIOUS PATIENT, BUT THE INDIVIDUAL MODULES COULD EITHER SHOW THE PREVIOUS PATIENT'S DATA OR COULD SHOW THE NEW PATIENT'S DATA DEPENDING ON WHEN THE ERROR OCCURRED DURING THE CODE WORKFLOW. FOR EXAMPLE, PATIENT INFO, PROFILE, AND FLOWSHEET COULD SHOW THE OLD PATIENT WHILE PATIENT REGISTRY, AND VITAL SIGNS COULD SHOW THE NEW PATIENT'S DATA. ENGINEERING COULD REPRODUCE THIS ISSUE IN-HOUSE BY FORCING AN ERROR TO OCCUR WHILE SWITCHING PATIENTS. THE USER WOULD RECEIVE THE GENERIC "AN UNHANDLED EXCEPTION HAS OCCURRED" MESSAGE, BUT COULD CONTINUE AND THUS VIEW / ENTER DATA FOR THE OLD INCORRECT PATIENT. AFTER KNOWING WHERE IN THE CODE THIS ISSUE COULD OCCUR, ENGINEERING LOGGED BACKED INTO THE CUSTOMER'S SERVERS, LOOKED AT THEIR ERROR LOGS, AND DID CONFIRM THAT THEY HAD NETWORK ERRORS AT THE TIME THEY WERE NAVIGATING TO THE NEXT PATIENT. A DEFECT WAS OPENED FOR THE ISSUE TO DEVELOP A CORRECTION. A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY OTHERS WITH SIMILAR ISSUES. THIS INFORMATION IS BEING TRACKED AND TRENDED IN QUALITY.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT DOCUMENTS THE FIELD ACTION NUMBER AS THE DECISION WAS MADE POST SUBMISSION OF THE INITIAL MDR.

    Description of Event or Problem · 1

    USER REPORTED THAT WHEN ACCESSING A PATIENT'S REGISTRY TAB, THEY WILL SOMETIMES SEE A DIFFERENT PATIENT'S DATA. ADDITIONALLY, THE CALLER NOTED THAT USUALLY THE USER IS IN CARE PLAN AND THEN GOES TO THE REGISTRY WHEN THIS OCCURS. THE ISSUE IS INTERMITTENT AND WAS NOTICED WHEN THE PRODUCT WAS UPGRADED. IF THE USER MOVES OUT OF THE REGISTRY TAB AND THEN BACK IN, THE CORRECT DATA DISPLAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547950 ARGUS SYSTEM ECAREMANAGER V. 4.0.1 MSX PHILIPS VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1