BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 2040285 · Received February 15, 2011

    Report

    Report Number
    2954704-2011-00004
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. THE MALFUNCTION IS CURRENTLY UNDER DEFECT INVESTIGATION AND HEALTH HAZARD EVALUATION. THE DEVICE IS SOFTWARE AND RESIDES AT THE CUSTOMER FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER IDENTIFIED THE FOLLOWING BEHAVIOR DURING TESTING: PATIENT A = (B)(6), PATIENT B = (B)(6). PATIENT A'S RECORDS ARE LINKED BETWEEN MULTIPLE FACILITIES (LOCATIONS). PATIENT B IS IDENTIFIED AS THE SAME PERSON AS PATIENT A, AND A MERGE IS CONDUCTED BETWEEN A AND B WITHIN ONE FACILITY. THE LINKS FOR PATIENT A AT ALL FACILITIES WILL BE RETAINED IF PATIENT A IS RETAINED IN THE MERGE AND PATIENT B IS ABSORBED. THE LINKS FOR PATIENT A AT ALL FACILITIES WILL BE LOST IF PATIENT B IS RETAINED IN THE MERGE AND PATIENT A IS ABSORBED.

    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