BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE CT 64 SLICE CONFIGURATION

    MDR report key: 922410 · Received October 2, 2007

    Report

    Report Number
    1525965-2007-00024
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 13, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    1525965-06/25/07-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 25, 2007, PHILIPS MEDICAL SYSTEMS TOOK ACTION TO ADVISE THE INSTALLED BASE OF THIS MATTER THROUGH A PRODUCT SAFETY NOTIFICATION AND PHILIPS MEDICAL SYSTEMS WILL UPDATE THE CUSTOMERS' SYSTEMS TO MITIGATE THIS ISSUE. UPON REVIEW OF THE COMPLAINT FILES, PHILIPS MEDICAL SYSTEMS DETERMINED THAT THIS EVENT IS SIMILAR IN NATURE TO MDR REPORT 1525965-2007-00006 AND A DECISION WAS REACHED TO FILE AN MDR ON THIS EVENT.

    Description of Event or Problem · 1

    HOSPITAL HAD RECENTLY STARTED TO USE THE BRILLIANCE 64 FOR NON-CONTRAST HEAD EXAMINATIONS. THE SITE HAS DISCOVERED TWO CASES THAT HAVE EXHIBITED THE BUTTON ARTIFACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE CT 64 SLICE CONFIGURATION COMPUTED TOMOGRAPHY SCANNER JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR