BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3022609 · Received March 22, 2013

    Report

    Report Number
    1525965-2013-00064
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Report Date
    February 22, 2013
    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
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ON OR ABOUT (B)(6) 2013, THE CUSTOMER REPORTED IMAGE QUALITY PROBLEMS AND AN ARTIFACT PRESENT IN PATIENT HEAD CT SCANS. THERE WAS NO REPORT OF MISINTERPRETATION, MISTREATMENT OR RESCAN OF A PATIENT. PHILIPS SERVICE DETERMINED THE REPORTED IMAGE QUALITY PROBLEMS AND THE REPORTED ARTIFACTS WERE DUE TO THE TEMPERATURE CORRECTION (TCOR) CALIBRATION NOT FUNCTIONING PROPERLY. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE TEMPERATURE CORRECTION OPTION OF THE DMS COVER WAS FUNCTIONING INCORRECTLY. THE FSE REPLACED TWO MODULES AND REINSTALLED THE CONSOLE AND IRS SOFTWARE AND PERFORMED RELEVANT CALIBRATIONS, WHICH RESOLVED THE ARTIFACT ISSUE. AFTER SERVICE WAS COMPLETED, THERE WAS NO FURTHER RECURRENCE AT THIS SITE. CT ENGINEERING INVESTIGATION DETERMINED A PROBABLE CAUSE WAS A TEMPERATURE CORRECTION FAILURE DUE TO THE FAILURE OF THE TWO MODULES THAT WERE REPLACED. THE FAILED MODULES OR LOG FILES WERE NOT AVAILABLE AND WERE NOT PROVIDED FOR ENGINEERING ASSESSMENT. THE FSE REPLACED TWO MODULES AND PERFORMED ALL RELEVANT CALIBRATIONS TO RESOLVE THE ISSUE. SINCE THERE WERE NO PARTS RETURNED FROM THE FIELD OR LOG FILES PROVIDED, A CAUSE OF THE ISSUE COULD NOT BE DETERMINED BY ENGINEERING. HOWEVER, BASED UPON THE TROUBLESHOOTING SERVICES AND STATEMENTS OF THE FSE, ENGINEERING DETERMINED A PROBABLE CAUSE WAS A TEMPERATURE CORRECTION FAILURE DUE TO THE FAILURE OF THE TWO MODULES THAT WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMAGE QUALITY PROBLEMS AND AN ARTIFACT PRESENT IN PT HEAD CT SCANS. THERE WAS NO REPORT OF MISINTERPRETATION, MISTREATMENT, OR RESCAN OF A PT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMAGE QUALITY PROBLEMS AND AN ARTIFACT PRESENT IN PATIENT HEAD CT SCANS. THERE WAS NO REPORT OF MISINTERPRETATION, MISTREATMENT, OR RESCAN OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119080 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1