BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 7100523 · Received December 8, 2017

    Report

    Report Number
    1525965-2017-00067
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Report Date
    May 5, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THERE WERE ARTIFACTS ON A HEAD SCAN. THERE WAS NO REPORT OF MISREPRESENTATION AS A RESULT OF THE RING ARTIFACTS. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) HAD THE CUSTOMER SHUTDOWN AND REBOOT THE SYSTEM. AFTER RUNNING AIR CALIBRATIONS AND PERFORMING A HEAD TEST SCAN, THE ARTIFACT WAS STILL PRESENT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO EVALUATE THE SYSTEM. THE FSE CONFIRMED THE RING ARTIFACTS WERE PRESENT ON SCAN IMAGES IN THE REGION OF INTEREST (ROI). THE FSE VISUALLY INSPECTED THE SYSTEM AND FOUND A CRACK IN THE FILTER (COMPENSATOR) OF THE A-PLANE COLLIMATOR. THE FSE REPLACED THE COLLIMATOR TO RESOLVE THE ISSUE. THE FSE CONFIRMED THERE WAS NO IMPACT TO A PATIENT AND NO REPORT OF MISREPRESENTATION AND/OR MISTREATMENT AS A RESULT OF THIS REPORTED ISSUE. THE SYSTEM IS IN CLINICAL USE. THIS ISSUE WAS DETERMINED NOT TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THERE WERE ARTIFACTS ON A HEAD SCAN. THERE WAS NO REPORT OF MISREPRESENTATION AS A RESULT OF THE RING ARTIFACTS. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) HAD THE CUSTOMER SHUTDOWN AND REBOOT THE SYSTEM. AFTER RUNNING AIR CALIBRATIONS AND PERFORMING A HEAD TEST SCAN, THE ARTIFACT WAS STILL PRESENT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO EVALUATE THE SYSTEM. THE FSE CONFIRMED THE RING ARTIFACTS WERE PRESENT ON SCAN IMAGES IN THE REGION OF INTEREST (ROI). THE FSE VISUALLY INSPECTED THE SYSTEM AND FOUND A CRACK IN THE FILTER (COMPENSATOR) OF THE A-PLANE COLLIMATOR. THE FSE REPLACED THE COLLIMATOR TO RESOLVE THE ISSUE. THE FSE CONFIRMED THERE WAS NO IMPACT TO A PATIENT AND NO REPORT OF MISREPRESENTATION AND/OR MISTREATMENT AS A RESULT OF THIS REPORTED ISSUE. THE SYSTEM IS IN CLINICAL USE. THIS ISSUE WAS DETERMINED NOT TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ENGINEERING ANALYSIS CONCLUDED THAT THIS EVENT HAS THE POTENTIAL TO RESULT IN IMAGE MISINTERPRETATION DUE TO AN ARTIFACT FROM A DEGRADED COMPENSATOR WITHIN THE COLLIMATOR. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880300 BRILLIANCE 64 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1