BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1468555 · Received July 22, 2009

    Report

    Report Number
    2954704-2009-00013
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Removal / Correction Number
    Z-0399-2006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. PRODUCT CAN BE EVALUATED AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. CUSTOMER WAS PREVIOUSLY SUBJECT TO RECALL Z-0399-2006. CORRECTION WAS TO PATCH AFFECTED VERSION INSTALLED AT CUSTOMER SITE(S). RECORD FOR CUSTOMER (REPORTING THIS ISSUE) FROM RECALL, INDICATING NOTIFICATION OF RECALL AND INSTALLATION OF PATCH CORRECTION DATED DECEMBER, 2005. NOVEMBER, 2008, CUSTOMER INSTALLED A NEW WORKSTATION. THE CUSTOMER PERFORMS WORKSTATION/CLIENT INSTALLATION BY PULLING THE APPLICATION EXECUTABLE(S) FROM THE LOCATION ON THE SERVER. CUSTOMER DID THIS, BUT FORGOT TO INSTALL THE PATCH CORRECTION WITH THE BUILD. WHILE TESTING THE NEW WORKSTATION, CUSTOMER IDENTIFIED AND REPORTED THIS ISSUE. WHEN THEY CALLED, THEY WERE REMINDED OF THE MANDATORY PATCH FOR THAT SOFTWARE VERSION. CUSTOMER THEN INSTALLED THE PATCH TO THE WORKSTATION TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    NO REPORT OF PATIENT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED THE WORKSTATION IS SHOWING TWO PATIENTS AT THE SAME TIME.

    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