BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 18031056 · Received October 30, 2023

    Report

    Report Number
    3015777306-2023-00022
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 4, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER WAS UPDATED FROM NO TO YES. PHILIPS RECEIVED A COMPLAINT REGARDING THE BRIGHTVIEW XCT SYSTEM AT ADVENTHEALTH WATERMAN. ON (B)(6) 2023, THE OPERATOR PREPARED THE SYSTEM FOR QUALITY ASSURANCE (QA) TESTING AND AS GANTRY ROTATION BEGAN, THE CT FLAT-PANEL DETECTOR (FPD) UNLATCHED AND CONTACTED THE FACE OF THE DETECTOR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR BYSTANDER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM. THE FSE DETERMINED THE OPERATOR DID NOT ENSURE PROPER POSITIONING OF FPD AT THE DEPLOYED POSITION. THE FPD AND ARM WERE NOT IN THE LOCKING POSITION, AND WHEN THE OPERATOR ATTEMPTED TO PUSH THE BLACK HANDLE, MISALIGNMENT DID NOT ALLOW THE MECHANISM TO LOCK. THE OPERATOR RECOGNIZED THE LOCKING MECHANISM WAS STIFF AND REQUIRED MORE PRESSURE TO GET THE HANDLE TO THE LOCKED POSITION. THE TECHNOLOGIST FORCED THE HANDLE INTO A FALSELY LOCKED POSITION; HOWEVER, THE EXCESSIVE FORCE ON THE BLACK HANDLE CAUSED THE LINKAGE TO BEND. THIS SERIES OF EVENTS LED TO THE TORSIONAL SPRING LOCKING PIN FAILURE DURING GANTRY ROTATION. DAMAGED FPD COMPONENTS WERE REPLACED BY THE FSE: DOWEL PIN 5/16 DIA X 5/8 LONG SS 18-8, MACH LINKAGE ROT, TRANSFER, DET -PIVOT. NO OTHER SYSTEM DAMAGE WAS INCURRED; THE SYSTEM WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. LOG FILES WERE COLLECTED FOR FURTHER ANALYSIS. A TECHNICAL INVESTIGATION WAS PERFORMED BY PHILIPS ENGINEERING: REPEATED USE OF EXCESSIVE FORCE ON THE HANDLE WILL RESULT IN PROGRESSIVE BENDING OF THE PIVOT LINKAGE. THIS IS RECOGNIZABLE, AS THE HANDLE BECOMES PROGRESSIVELY MORE RIGID AND MORE FORCE IS REQUIRED TO DEPLOY THE FPD FROM THE STOWED POSITION. DURING THE PLANNED MAINTENANCE EVENTS WHICH ARE PERFORMED EVERY SIX MONTHS, THE FSE MEASURES THE FORCE REQUIRED TO LOCK THE FPD IN THE DEPLOYED POSITION, INTENDING TO IDENTIFY AN OCCURRENCE OF THE ISSUE AT AN EARLY STAGE. IF THE FORCE IS HIGHER THAN SPECIFIED, THE DAMAGED COMPONENTS IN THE LOCKING MECHANISM ARE REPLACED. FOR THIS SYSTEM, PLANNED MAINTENANCE OCCURRED ON (B)(6) 2023, AND THE LOCK HANDLE FORCE WAS WITHIN SPECIFICATION. THERE WERE NO REPORTED ISSUES WITH THE FPD AFTER PLANNED MAINTENANCE AND PRIOR TO THIS EVENT. LOG FILE ANALYSIS CONFIRMED THE FOLLOWING: USER-INITIATED FPD DEPLOYMENT WAS NOT SUCCESSFUL. MULTIPLE WARNINGS WERE DISPLAYED TO THE OPERATOR REGARDING THE FPD UNLATCHED STATUS. EMERGENCY STOPS WERE TRIGGERED BY THE SOFTWARE EACH TIME THE OPERATOR ATTEMPTED TO INITIATE SYSTEM MOTION DUE TO THE FPD NOT BEING LOCKED IN POSITION. ENGINEERING CONCLUDED THE CAUSE OF THE TORSIONAL SPRING FAILURE AND BENDING OF THE PIVOT LINKAGE WAS FORESEEABLE MISUSE. THE OPERATOR DID NOT ENSURE PROPER POSITIONING OF FPD AT THE DEPLOYED POSITION. THE TECHNOLOGIST FORCED THE HANDLE INTO A FALSELY LOCKED POSITION, ALTHOUGH THE EXTRA FORCE WAS A SIGN OF FAILURE. THE EXCESSIVE FORCE ON THE BLACK HANDLE CAUSED THE LINKAGE TO BEND. SYSTEM WARNING MESSAGES AND EMERGENCY STOPS WERE DISREGARDED. CONCLUSION: NO FURTHER ACTION IS REQUIRED; THE CAUSE OF THE PART FAILURE WAS REPEATED FORESEEABLE MISUSE.

    Description of Event or Problem · 0

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THIS ISSUE REPORTED WAS THE FLAT PANEL RELEASED WITHOUT COMMAND AND MADE CONTACT WITH THE GANTRY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009512 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown