BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 12346250 · Received August 19, 2021

    Report

    Report Number
    3015777306-2021-10008
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 22, 2021
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE INITIALLY REPORTED WAS THAT THE XCT FLAT PANEL DETECTOR (FPD) WAS UNABLE TO BE UNLOCKED. THE SYSTEM WAS IN NOT CLINICAL USE WHEN THIS OCCURRED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED AND DETERMINED THE FPD LINKAGE WAS TWISTED AND BENT DUE TO IMPROPER HANDLING/PROCEDURE BY THE USER. THE FSE REPORTED AFTER INTERVIEW WITH THE CUSTOMER, THAT AFTER PERFORMING MORNING QUALITY CONTROL, THE USER FORGOT TO LOCK THE LOCKING HANDLE OF THE FPD AND WHEN THE GANTRY WAS ROTATED, THE FPD SWUNG FREELY BREAKING THE SPRING AND ALLOWING THE FLAT PANEL TO OVEREXTEND DOWN INTO THE CENTER OF THE GANTRY. THE SYSTEM WAS REMOVED FROM CLINICAL USE UNTIL THE DAMAGED FPD LINKAGE WAS REPLACED TO RESOLVE THE ISSUE. PHILIPS ENGINEERING REVIEWED ALL INFORMATION AND CONCLUDED: THE FPD CAN BE LOCKED AT THE DEPLOY POSITION WHEN THE GANTRY IS AT +90DEGREES (FPD AT 3 O¿CLOCK POSITION). THE SYSTEM CONSISTS OF SENSORS THAT ARE POSITIONED IN SUCH A WAY THAT IDENTIFIES THE POSITION OF THE LOCKING HANDLE. IN THE CASE OF A MALFUNCTION IN THE LINKAGE ASSEMBLY, IF THE INCIDENT WAS UNNOTICED AND THE OPERATOR CONTINUED USING THE SYSTEM (I.E., LOCKING HANDLE IS IN ¿LOCKED¿ POSITION BUT FPD IS NOT FULLY LOCKED), AS THE GANTRY WOULD START TO ROTATE, AT +86DEG, THE FPD WOULD SWING SLOWLY. THIS SITUATION WOULD ALSO LIMIT THE USABILITY OF THE BRIGHTVIEW XCT SYSTEMS (UNABLE TO PERFORM ALL SCANS AND COLLIMATOR EXCHANGE). FURTHERMORE, PER THE INSTRUCTIONS FOR USE MANUAL FOR BRIGHTVIEW XCT: DO NOT ATTEMPT TO DEPLOY OR STOW THE FPD WITHOUT FIRST PERFORMING THE DEPLOY PANEL OR STOW PANEL PPM. MAKE SURE THAT THE FPD LATCH MECHANISM IS LOCKED BEFORE YOU START AN X-RAY SCAN. THE SYSTEM SENSES THAT THE LATCH MECHANISM IS NOT LOCKED AND ACTIVATES AN EMERGENCY STOP. VIGILANTLY WATCH THE PATIENT TO MAKE SURE THAT EQUIPMENT OR PATIENT MOTION DOES NOT RESULT IN PATIENT HARM OR EQUIPMENT DAMAGE. MONITOR THE PATIENT AND THE SYSTEM DURING ANY SYSTEM MOTIONS TO MAKE SURE THAT PATIENT MOTION OR SYSTEM MOTION DOES NOT RESULT IN PATIENT HARM OR EQUIPMENT DAMAGE. THE PROBABLE CAUSE WAS IMPROPER HANDLING OF THE FPD BY THE USER. THIS EVENT IS CONSIDERED A NON-REPORTABLE EVENT. DATE OF REPORT: 20210917.

    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. A PHILIPS FIELD SERVICE REPORTED THE XCT FLAT PANEL LINKAGE WAS BENT DUE TO IMPROPER USER HANDLING. THIS EVENT IS CURRENTLY UNDER INVESTIGATION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    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: COMPLAINT PR# (B)(4). (B)(4). DATE OF REPORT: 2021 08 19.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. A PHILIPS FIELD SERVICE REPORTED THE XCT FLAT PANEL LINKAGE WAS BENT DUE TO IMPROPER USER HANDLING. THIS EVENT IS CURRENTLY UNDER INVESTIGATION. 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
    1243066 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1