BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 15810313 · Received November 16, 2022

    Report

    Report Number
    3015777306-2022-00008
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 25, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    PMA / PMN Number
    K0080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOT COMPLETED OUT INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR#(B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER WAS UPDATED FROM NO TO YES. THE ISSUE REPORTED WAS AN ERROR MESSAGE OCCURRED INDICATING THE FLAT PANEL DETECTOR (FPD) WAS NOT LATCHED IN THE STOWED POSITION. THE FPD BECAME DISLODGED WHEN GANTRY ROTATION WAS INITIATED AND CAUSED DAMAGE TO THE DETECTOR ONE COVERS. THE SYSTEM WAS NOT IN CLINICAL USE AND THERE WAS NO REPORT OF HARM TO AN OPERATOR OR BYSTANDER. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. A VISUAL INSPECTION OF THE SYSTEM CONFIRMED DAMAGE TO THE DETECTOR ONE COVERS. SYSTEM USE WAS DISCONTINUED UNTIL REPAIRS WERE COMPLETED. UPON FURTHER EVALUATION, THE FSE FOUND THE FORK SPRING LATCH THAT HOLDS THE FPD TO THE GANTRY IN THE STOWED POSITION WAS WORN. THE FSE REPLACED THE FLAT PANEL LATCH ASSEMBLY, AND THE DETECTOR ONE COVERS. THE SYSTEM WAS RETURNED TO CUSTOMER FULLY OPERATIONAL AND WORKING WITHIN SPECIFICATION. PHILIPS ENGINEERING PERFORMED A TECHNICAL INVESTIGATION BUT WAS UNABLE TO REPRODUCE THE ISSUE. MULTIPLE TESTS WERE PERFORMED, AND CONFIRMED THAT GANTRY MOTION HALTED, AND THE EXPECTED ERROR MESSAGE APPEARED EACH TIME. ENGINEERING DETERMINED THAT IN THIS CASE, THE WORN FORK SPRING LATCH LED TO THE FPD BEING LOOSENED FROM ITS STOWED POSITION WITH RESPECT TO THE GANTRY ARM SUPPORT. WHEN GANTRY ROTATION WAS ATTEMPTED, THE SYSTEM HALTED FURTHER GANTRY MOTION AND TRIGGERED A WARNING MESSAGE. PER ENGINEERING, FAILURE OF THE FORK SPRING LATCH WOULD NOT ALLOW THE FPD TO BECOME FULLY DISLODGED FROM STOWED POSITION, AS THERE IS AN ADDITIONAL MECHANICAL LATCH IN PLACE THAT WOULD RESTRICT FURTHER MOVEMENT BY DESIGN. THE LATCHING MECHANISMS OF FLAT PANEL DETECTOR ARE INSPECTED AND EVALUATED FOR SIGNS OF WEAR DURING PLANNED MAINTENANCE (PM). IN THIS CASE, THE CUSTOMER POSTPONED PM SEVERAL TIMES, AND THE PM WHICH SHOULD HAVE OCCURRED IN AUGUST WAS NOT COMPLETED UNTIL LATE DECEMBER, AFTER THIS EVENT OCCURRED. THE FSE CONFIRMED THAT THIS ISSUE WOULD HAVE BEEN IDENTIFIED DURING THE PM HAD IT BEEN PERFORMED AT THE REGULARLY SCHEDULING INTERVAL. THE PROBABLE CAUSE OF THE FPD BECOMING DISLODGED WAS A WORN FORK SPRING LATCH, WHICH WOULD HAVE BEEN IDENTIFIED PRIOR TO THE FAILURE DURING PM HAD THE PM NOT BEEN POSTPONED MULTIPLE TIMES BY THE CUSTOMER. BASED ON INVESTIGATION CONCLUSION, THIS ISSUE IS NOT REPORTABLE. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    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. THE ISSUE REPORTED WAS THE FLAT PANEL DETECTOR (FPD) DID NOT REMAIN IN THE STOWED POSITION AND DISLODGED DURING GANTRY MOTION, CAUSING DAMAGE TO THE COVER ON DETECTOR ONE (DET1) AND EXPOSING THE DETECTOR ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830750 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown