BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE BIG BORE ONCOLOGY

    MDR report key: 4093233 · Received September 4, 2014

    Report

    Report Number
    1525965-2014-00154
    Date Received
    September 4, 2014
    Report Date
    August 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT AT THIS TIME. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE LINES GOING THROUGH THE CORONAL AND SAGITTAL IMAGES FOR AXIAL BRAIN PROCEDURES UTILIZING TILT AND SOME AXIAL SLICES WERE LIGHTER. PHILIPS SERVICE CONFIRMED THAT THE INITIAL INTERPRETATION OF THE PATIENT'S IMAGES (ACQUIRED ON A BRILLIANCE BIGBORE CT SYSTEM) WAS A BRAIN HEMORRHAGE. THIS RESULTED IN THE PATIENT BEING ADMITTED FOR A NEURO CONSULT. THE PATIENT THEN HAD A MAGNETIC RESONANCE IMAGINING (MRI) PROCEDURE, A MAGNETIC RESONANCE ANGIOGRAM (MRA) PROCEDURE AND A SUBSEQUENT COMPUTED TOMOGRAPHY (CT) PROCEDURE ON THE CUSTOMER'S INGENUITY 128 SYSTEM, WHICH CONFIRMED THAT THE BRAIN HEMORRHAGE WAS ACTUALLY AN ARTIFACT. PHILIPS SERVICE STATED THAT THERE WAS AN INTERMITTENT BULLS-EYE ARTIFACT. THE A-PLANE COLLIMATOR WAS REPLACED TO RESOLVE THE ISSUE. PHILIPS PHYSICS REVIEWED THE IMAGES AND NOTED THAT: NO BULLSEYE ARTIFACT WAS FOUND; IMAGES DID SHOW A NOTICEABLE BRIGHTENING EVERY 16TH IMAGE ON IMAGES AT THE EDGE OF THE COLLIMATION; THE LINES ON THE MPRS ARE CONSISTENT WITH THE IMAGES THAT BRIGHTEN EVERY 16 SLICES; DISTANCE BETWEEN LINES ON THE MPR MEASURES 12 MM WHICH CORRESPONDS TO THE COLLIMATION THICKNESS USED FOR THE SCAN, 16X0.75MM ON THE BIG BORE SCANNER. ALL OF THIS IS CONSISTENT WITH THE COLLIMATOR CAUSING THE ISSUE BY PARTIALLY OBSTRUCTING ONE OF THE EDGE SLICES WITH THE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539494 BRILLIANCE BIG BORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1