BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 11787327 · Received May 6, 2021

    Report

    Report Number
    3015777306-2021-10004
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE REPORTED WAS THAT THE DETECTOR HEAD WAS MOVING WITHOUT BEING PROMPTED AND WOULD NOT STOP. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THIS OCCURRED AND THERE WAS NO HARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE AND CONFIRM THE REPORTED ISSUE. THE FSE STATED THAT THE GANTRY CONTINUED TO MOVE AFTER THE BUTTON ON THE HAND CONTROLLER WAS RELEASED. THE FSE REVIEWED SYSTEM LOGS AND TRIED TO REPRODUCE THE ERROR AND FOUND THAT THE DEVICE ENABLE SIGNAL HAD ACTIVATED WITHOUT PRESSING ANY BUTTONS ON THE REMOTE HAND CONTROLLER. THE FSE UNPLUGGED THE REMOTE HAND CONTROLLER BATTERY POWER TO RESET IT. THEN CHECKED AND CALIBRATED ALL GANTRY MOTIONS AND PERFORMED REMOTE HAND CONTROLLER/PPM (PREPROGRAMMED MOTION) TESTS WHICH WERE ALL GOOD. THE SYSTEM WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. PHILIPS ENGINEERING REVIEWED ALL AVAILABLE INFORMATION AND CONCLUDED THE FOLLOWING: LOGFILES WERE REQUESTED FOR ANALYSIS HOWEVER WERE NOT AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THE UNCOMMANDED MOTION WAS STOPPED BY USER INTERVENTION. THE SYSTEM IS EQUIPPED WITH EMERGENCY STOP BUTTONS AND COLLISION SENSORS TO HALT MOTION. USERS SHOULD BE VIGILANT WHILE WATCHING THE PATIENT AND CONTROLLING THE MACHINE SIMULTANEOUSLY AND CAN ACTIVATE THE E-STOP IN CASE OF ANY UNEXPECTED MOTION. THE PROBABLE CAUSE WAS A COMMUNICATION ISSUE BETWEEN THE WIRELESS HAND CONTROLLER AND THE SYSTEM. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4). (B)(4).

    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. THE ISSUE REPORTED WAS THAT THE DETECTOR HEAD WAS MOVING WITHOUT BEING PROMPTED AND WOULD NOT STOP. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THIS EVENT OCCURRED. 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
    683124 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW X

    Patients

    Seq Age Sex Outcome Treatment
    1