BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PACS BREAST SUITE

    MDR report key: 10559572 · Received September 21, 2020

    Report

    Report Number
    10559572
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    May 4, 2020
    Report Date
    September 17, 2020
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN THE PACS SUITE FOR MAMMOGRAPHY IMAGES, IN THE DIAGNOSTIC VIEW (LM VIEW)THE PACS WILL READ AND LABEL THE LEFT 3D TOMO INDICATOR BAR AS REVERSED IN ORIENTATION ON PACS ON BREAST TOMOS (I.E. LATERAL BREAST REGISTERS AS "M" FOR MEDIAL, AND VICE VERSA) FOR THE HOLOGIC AFFIRM PRONE BIOPSY SYSTEM AND THE GE ESSENTIAL WITH SENOCLAIRE. THIS HAS BEEN RECOGNIZED BY THE RADIOLOGISTS AND THEY ARE AWARE OF ITS OCCURRENCE. PHILIPS WAS FIRST CONTACTED ABOUT THIS OBSERVATION IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026548 INTELLISPACE PACS BREAST SUITE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1