BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1696541 · Received May 17, 2010

    Report

    Report Number
    2954704-2010-00005
    Event Type
    Other
    Date Received
    May 17, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 3, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. WORKING WITH XIRIS TO INVESTIGATE THIS OCCURRENCE, IT WAS DETERMINED THAT WHEN XIRIS IMPLEMENTATION OCCURRED, THE MANUAL HL7 MAPPING OF PT ID FROM XIRIS TO ISITE PACS WAS DONE ERRONEOUSLY. INSTEAD OF MAPPING THE UNIQUE PT ID FIELD IN XIRIS (PAT NUMBER) TO UNIQUE PT ID FIELD IN ISITE PACS (MRN), A NON-UNIQUE XIRIS FIELD (PAT ALT NUMBER) WAS MAPPED IN ERROR. ALL EXAMS WITH THE PAT ALT NUMBER WERE THEN ASSOCIATED TO THE ONE PT IN ISITE PACS FOR WHICH THE PAT ALT NUMBER WAS MAPPED. XIRIS HAS CORRECTED THE MAPPING FOR THIS CUSTOMER, AND ALL AFFECTED DATA HAS BEEN CORRECTED/RESTORED. NEITHER ISITE PACS NOR XIRIS MALFUNCTIONED. BOTH PRODUCTS ARE WORKING AS DESIGNED. THIS WAS A MANUAL IMPLEMENTATION ERROR, WHICH HAS ALREADY BEEN CORRECTED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT PT IN XIRIS HAS THREE ASSOCIATED EXAMS, BUT SAME PT IN ISITE PACS HAS MULTIPLE ASSOCIATED EXAMS FROM DIFFERENT PTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1