BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 2118633 · Received May 27, 2011

    Report

    Report Number
    2954704-2011-00006
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 27, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN HL7 MERGER MESSAGE WAS SENT TO MERGE TWO PATIENTS WITH THE SAME MEDICAL RECORD NUMBER (MRN). THIS CAUSED THE EXAMS TO GET DELETED IN THE DATABASE. THE EXAMS AND IMAGES ARE RETAINED, BUT THE DATABASE BELIEVES THEY ARE DELETED. THIS MAY CAUSE A DELAY IN TREATMENT. A DATABASE TABLE CAN BE UPDATED AND THE PATIENT AND EXAMS ARE AGAIN VIEWABLE.

    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