BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1442851 · Received May 15, 2009

    Report

    Report Number
    2954704-2009-00004
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 16, 2009
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS INC
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    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. WE ARE ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. THIS ISSUE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. A CUSTOMER REPORTED THAT WHEN BURNING EXAMS TO CD, DELETED IMAGES ARE SHOWING ON CD.

    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 NA