BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIA DISTRIBUTOR CENTER

    MDR report key: 3836392 · Received January 24, 2014

    Report

    Report Number
    3007584706-2014-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Report Date
    November 8, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD., PHILIPS HEALTHCARE, PCCI SEM PACS
    Product Code
    LLZ
    PMA / PMN Number
    K072960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PHILIPS VSS PACS HAS DISCOVERED A POTENTIAL PROBLEM WITH THE PHILIPS MDC PACS AND INTELLISPACE PACS DCX (ALL VERSIONS) WHILE TESTING IN VSS PACS LAB. MEASURING OF PIXEL DENSITY AND STATISTICS FOR REGION OF INTEREST PRESENTS INCORRECT VALUES IN ENHANCED MR AND ENHANCED CT IMAGES WHEN MODALITY LUT IS DEFINED IN DICOM FUNCTIONAL GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55727 MEDIA DISTRIBUTOR CENTER LLZ PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD., PHILIPS HEALTHCARE, PCCI SEM PACS 830044

    Patients

    Seq Age Sex Outcome Treatment
    1