BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 2263977 · Received September 8, 2011

    Report

    Report Number
    2954704-2011-00009
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS SOFTWARE PACKAGE VER.4X IS USED WITH GENERAL COMPUTING HARDWARE TO ACQUIRE, STORE, DISTRIBUTE, PROCESS AND DISPLAY IMAGES AND ASSOCIATED DATA THROUGHOUT A CLINICAL ENVIRONMENT. EASYRIS IS A RADIOLOGY INFO SYSTEM (RIS) WHICH STORES AND DISTRIBUTES PT RADIOLOGICAL DATA. THE SYSTEM CONSISTS OF PT TRACKING AND SCHEDULING, RESULT REPORTING AND IMAGE TRACKING CAPABILITIES. RIS AND PACS ARE TWO DIFFERENT SYSTEMS AND EXCHANGE PT AND ORDER INFO VIA STANDARDS SUCH AS HL-7 AND DICOM RESPECTIVELY. RIS IS RESPONSIBLE FOR MANAGING THE ADMINISTRATIVE AND REPORTING WORKFLOWS IN RADIOLOGY; PACS IS RESPONSIBLE FOR MANAGING THE IMAGE READING WORKFLOW. THE REPORTED EVENT IS CURRENTLY UNDER INVESTIGATION. THE REPORTED EVENT HAS BEEN REVIEWED WITHIN THE PHILIPS SAFETY COMMITTEE AND A HEALTH HAZARD EVALUATION (HHE) HAS ALSO BEEN INITIATED. THE DEVICE IS SOFTWARE AND RESIDES AT THE CUSTOMER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT EXAMS RELATED TO PTS WITH OVERLAPPING IDENTIFICATIONS WERE PARTIALLY ATTACHED TO THE WRONG PT IN ISITE PACS. FOR EXAMPLE: PT A HAD THEIR MRN GENERATED FROM THE RADIOLOGY INFO SYSTEM (RIS) ((B)(4)) AND CONTAINED TWO EXAMS: EXAM 01, EXAM 02. PT B HAD THEIR MRN GENERATED FROM THE HOSP INFO SYSTEM (HIS) (ALSO (B)(4)) AND CONTAINED THREE EXAMS: EXAM 03, EXAM 04, EXAM 05. WHEN THE EXAMS WERE SENT TO ISITE PACS, BECAUSE THE MRN WAS THE SAME, THE EXAMS WERE MERGED INTO ONE PT RECORD, SUCH THAT: PT A NOW HAS NO EXAMS. PT B HAS FIVE EXAMS BELONGING TO BOTH PT A AND PT B, EXAM 01 THROUGH EXAM 05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1