BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 24086986 · Received January 15, 2026

    Report

    Report Number
    3015777306-2026-100000
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 16, 2025
    Report Date
    March 6, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE DETECTOR DROP UPON THE LEAD SCREW FAILURE WAS DUE TO THE ABSENCE OF THE RADIAL SAFETY PLATE. BY DESIGN, THE RADIAL SAFETY PLATE PREVENTS UNCONTROLLED DETECTOR MOVEMENT IN THE EVENT OF LEADSCREW FAILURE BY LIMITING VERTICAL TRAVEL TO A MAXIMUM OF 3MM, THEREBY PREVENTING HARM. THE INVESTIGATION ALSO DETERMINED THAT THE RADIAL LEAD SCREW FRACTURED DUE TO MISALIGNMENT BETWEEN THE LEADSCREW AND THE LINEAR GUIDES. THIS MISALIGNMENT CAUSED CYCLIC FATIGUE TO THE HIGH STRESS INTERFACE BETWEEN THE LEADSCREW AND THE GEARBOX DURING NORMAL ROTATION. THE EXTENT OF MISALIGNMENT REDUCED THE SERVICE LIFE OF THE LEADSCREW AND ULTIMATELY LED TO FATIGUE FRACTURE. LEADSCREW ALIGNMENT FCO88200538 WAS COMPLETED ON SEPTEMBER 19, 2024. HOWEVER, THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE SYSTEM HAS BEEN SERVICED MULTIPLE TIMES BY A THIRD PARTY. INDICATING THAT, WITHIN THE LAST 15 MONTHS, SUBSEQUENT SERVICE ACTIVITIES MAY HAVE REINTRODUCED MISALIGNMENT. NO SERVICE RECORDS ARE AVAILABLE TO FURTHER EVALUATE. SAFETY PLATE FCO88200543 (BRIGHTVIEW X/XCT SAFETY PLATE INSTALLATION) WAS COMPLETED ON DECEMBER 17, 2024. HOWEVER, THE INVESTIGATION FOUND NO EVIDENCE THAT THE SAFETY PLATE WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONALLY, SERVICE WORK ORDER HISTORY SHOWS THAT THERE IS NO PLANNED MAINTENANCE (PM) PERFORMED ON THE SYSTEM SINCE DECEMBER 2020. FOR THIS EVENT, THE SYSTEM WAS BEING SERVICED BY A THIRD-PARTY SERVICE COMPANY CONTRACTED BY THE CUSTOMER. THE THIRD-PARTY SERVICE STAFF APPEARED TO HAVE NOT FOLLOWED PHILIPS PM INSTRUCTIONS AND REMOVED THE SAFETY PLATE WITHOUT REINSTALLING IT, LEAVING THE SYSTEM WITHOUT A CRITICAL SAFETY MITIGATION TO A PREVENT SERIOUS HARM. THE RISK RESULTING FROM THIS SERVICE MISUSE AND THE REMOVAL OF THE SAFETY MITIGATION IS DEEMED UNACCEPTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. UPON COMPLETION, A FOLLOW-UP EMDR REPORT WILL BE SUBMITTED. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 0

    DURING A LUNG SCAN ON BRIGHTVIEW XCT SYSTEM (MODEL 882482, SERIAL NUMBER (B)(6)), THE LEAD SCREW ON DETECTOR 2 FAILED, CAUSING THE DETECTOR TO UNEXPECTEDLY FREE-FLOAT DOWNWARD AND GENERATE A LOUD IMPACT NOISE. AT THE TIME, THE DETECTOR WAS IN THE UNDER-TABLE POSITION. THE PATIENT WAS MANUALLY REMOVED FROM THE TABLE, AND NO PATIENT INJURIES OCCURRED. FURTHER EVALUATION IDENTIFIED THAT THE LEAD SCREW FOR DETECTOR 2 HAD FRACTURED INTO TWO PIECES, RESULTING IN THE DETECTOR TO MOVE APPROXIMATELY SIX INCHES DOWNWARD TOWARD THE FLOOR. BASED ON THE AVAILABLE INFORMATION, THIS EVENT MEETS THE CRITERIA FOR A REPORTABLE MALFUNCTION, AS RECURRENCE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. PHILIPS HAS STARTED AN INVESTIGATION INTO THIS COMPLAINT. A FOLLOW-UP EMDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140063 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown