BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3841303 · Received May 20, 2014

    Report

    Report Number
    1525965-2014-00107
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 21, 2014
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2014, THE CUSTOMER AT (B)(6) OF (B)(6), REPORTED THAT DURING A PATIENT HEAD PROCEDURE, THE TRAINED PROFESSIONAL RECOGNIZED THAT THE IMAGES EXHIBITED A SPOT IN THE CENTER OF THE BRAIN WITH A SLIGHTLY DARKER DENSITY. THE TRAINED PROFESSIONAL DETERMINED THE IMAGES COULD NOT BE USED FOR INTERPRETATION. THE PHILIPS (FSE) CONFIRMED THAT THE PATIENT WAS SCANNED ON AN MRI SYSTEM TO RULE OUT ANY ISSUES. THE FSE RAN A DIAGNOSTIC TEST ON THE SYSTEM AND FOUND THAT THE CENTER DETECTOR MODULES IN THE DMS WERE OUT OF SPECIFICATION. THE FSE REPLACED THE MODULES IN THE DMS TO EVEN OUT THE GAIN DIFFERENCES AND CALIBRATED THE SYSTEM TO CORRECT THE ISSUE. ON (B)(6) 2015, THE PHILIPS FSE CONFIRMED THAT THERE WERE NO LOG FILES OR RAW DATA AVAILABLE FOR THIS EVENT. ON (B)(6) 2015, THE PHILIPS FSE CONFIRMED THAT THE ARTIFACT WAS A SLIGHT BANDING ARTIFACT IN THE CENTER OF THE HEAD AND WAS RECOGNIZED BY THE OPERATOR AS AN ISSUE WITH THE SYSTEM. IT WAS CONFIRMED THAT RAW DATA WAS NOT AVAILABLE FOR EVALUATION. DUE TO THE LACK OF RAW DATA, ENGINEERING IS UNABLE TO DETERMINE THE CAUSE OF THIS EVENT, HOWEVER, BASED UPON THE INFORMATION PROVIDED, THIS WAS LIKELY CAUSED BY AN ISSUE WITH THE DETECTOR MODULES IN THE DMS BEING OUT OF BALANCE. CT ENGINEERING DETERMINED THE RISK ASSESSMENT TO BE OF ACCEPTABLE RISK. IT HAS BEEN CONCLUDED THAT IF THIS EVENT WERE TO RECUR, IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. 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 IN INSTRUCTION FOR USE. IFU SHALL INCLUDE A NOTE THAT THE OPERATOR AND RADIOLOGIST SHOULD BE QUALIFIED WITH CT DIAGNOSTIC INCLUDING TYPICAL CT IMAGE ARTIFACTS. INSTRUCTION IN IFU TO PERFORM AIR CALIBRATION. THE SYSTEM SHALL BE OPERATED ONLY IF PERFORMANCE QUALITY ASSURANCE HAS BEEN SATISFACTORY 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) REPLACED THE MODULES IN THE DMS TO EVEN OUT THE GAIN DIFFERENCES AND CALIBRATED THE SYSTEM TO CORRECT THE ISSUE. THE FSE RAN A DIAGNOSTIC TEST ON THE SYSTEM AND FOUND THAT THE CENTER DETECTOR MODULES IN THE DMS WERE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PT HEAD PROCEDURE THE TRAINED PROFESSIONAL RECOGNIZED THAT THE IMAGES EXHIBITED A SHOT IN THE CENTER OF THE BRAIN WITH A SLIGHTLY DARKER DENSITY. THE TRAINED PROFESSIONAL DETERMINED THE IMAGES COULD NOT BE USED FOR INTERPRETATION. THE PHILLIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE PT WAS SCANNED ON AN MRI SYSTEM. THE FSE CONFIRMED THAT THE CENTER DETECTOR MODULES WERE OUT OF BALANCE AND DATA MEASUREMENT SYSTEM (DMS) DETECTOR BALANCING TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298533 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1