BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3080515 · Received April 24, 2013

    Report

    Report Number
    1525965-2013-00094
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Report Date
    March 26, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REF: COMPLAINT PR# (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL MDR MAILED ON APRIL 24, 2013; FOLLOW-UP #1 MDR MAILED ON OCTOBER 24, 2013. IN THIS CASE, PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER REPORTING THAT AN ARTIFACT FORMATION IS BEING OBSERVED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) DID NOT VISIT THE FACILITY. THERE IS NO REPORT OF RESCAN, MISINTERPRETATION, OR MISTREATMENT OF A PATIENT DUE TO THIS REPORTED ISSUE. THE CUSTOMER WAS UNABLE TO DESCRIBE THE TYPE OF ARTIFACT OTHER THAN IT WAS AN EASILY, RECOGNIZABLE, KNOWN ARTIFACT. NO PARTS WERE REPLACED, NO TESTS WERE RUN, AND NO LOG FILES WERE REVIEWED. THE PHILIPS FSE ADVISED THE CUSTOMER TO PERFORM AIR CALIBRATIONS ON THE SYSTEM. THE CUSTOMER PERFORMED AIR CALIBRATIONS AND CONFIRMED THE PROBLEM WAS RESOLVED. THE COMPLAINT WAS CANCELLED BY THE CUSTOMER SINCE THE PROBLEM STOPPED AFTER RESTARTING THE SYSTEM. CT ENGINEERING DETERMINED THIS EVENT TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS APPLY: * THE SYSTEM SHALL ALLOW THE USER TO RETROSPECTIVELY SELECT THE RECONSTRUCTION MODE OF RAW DATASETS AVAILABLE ON THE SYSTEM, INDEPENDENT OF THE PROSPECTIVELY SELECTED RECONSTRUCTION. * DAILY AND MONTHLY IMAGE QUALITY CHECKS BY OPERATOR ARE IN THE INSTRUCTION FOR USE (IFU). * IFU SHALL INCLUDE A NOTE THAT THE OPERATOR AND RADIOLOGIST SHOULD BE QUALIFIED WITH CT DIAGNOSTIC INCLUDING TYPICAL CT IMAGE ARTIFACTS. * INSTRUCTION IN IFU IS TO PERFORM AIR CALIBRATION. * THE SYSTEM SHALL BE OPERATED ONLY IF PERFORMANCE QUALITY ASSURANCE HAS BEEN SATISFACTORILY COMPLETED, AND THE PREVENTIVE MAINTENANCE PROGRAM IS UP TO DATE. IF ANY PART OF THE EQUIPMENT OR SYSTEM IS KNOWN (OR SUSPECTED) TO BE OPERATING IMPROPERLY OR WRONGLY-ADJUSTED, SYSTEM SHALL NOT BE USED UNTIL REPAIR IS MADE. * USER DOCUMENTATION SHALL WARN THE USER REGARDING FILTER CT# SHIFT. THE PHILIPS FSE ADVISED THE CUSTOMER TO PERFORM AIR CALIBRATIONS ON THE SYSTEM. THE CUSTOMER PERFORMED AIR CALIBRATIONS AND CONFIRMED THE PROBLEM WAS RESOLVED.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM THE CUSTOMER REPORTING AN "ARTIFACT FORMATION IS BEING OBSERVED", THERE IS NO REPORT OF RESCAN, MISINTERPRETATION, OR MISTREATMENT OF A PT DUE TO THIS REPORTED ISSUE. NO ADDITIONAL INFO IS AVAILABLE REGARDING THIS CUSTOMER ALLEGATION.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER REPORTING AN "ARTIFACT FORMATION IS BEING OBSERVED", THERE IS NO REPORT OF RESCAN, MISINTERPRETATION, OR MISTREATMENT OF A PATIENT DUE TO THIS REPORTED ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS CUSTOMER ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176040 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1