BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLIGHT IMAGING SYSTEM

    MDR report key: 11872481 · Received May 24, 2021

    Report

    Report Number
    3015777306-2021-10006
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    February 24, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    PMA / PMN Number
    K031705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE REPORTED WAS THAT GANTRY MOTION CONTINUED AFTER THE BUTTONS WERE RELEASED ON THE WIRELESS HAND CONTROLLER (HC). THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THERE WAS NO HARM AS A RESULT OF THIS EVENT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE AND CONFIRM THE REPORTED ISSUE. THE FSE REPORTED THAT SYSTEM MOTION HAD CONTINUED AFTER THE RELEASE OF THE WIRELESS HC FOR A FEW INCHES AT NORMAL SPEED UNTIL THE OPERATOR ACTIVATED A COLLISION SENSOR ON THE DETECTOR WHICH HALTED THE SYSTEM MOTION. THIS ISSUE OCCURRED ONE TIME AND THE OPERATOR STOPPED USE OF THE WIRELESS HC AND USED THE TOUCHSCREEN UNTIL THE HC WAS REPLACED. THE FSE REPLACED THE WIRELESS HC TO RESOLVE THE ISSUE. PHILIPS ENGINEERING REVIEWED ALL INFORMATION REGARDING THIS EVENT. THERE WERE NO LOG FILES CAPTURED FOR THIS EVENT FROM THE SITE. MOTION WAS STOPPED BY OPERATOR BY ACTIVATING THE COLLISION SENSOR ON THE DETECTOR. 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 E-STOP IN CASE OF ANY UNEXPECTED MOTION. PROBABLE CAUSE: FAULTY WIRELESS HAND CONTROLLER. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4). HEALTH IMPACT CODE: (B)(4): NO APPARENT HARM OCCURRED IN RELATION TO THE ADVERSE EVENT. DATE OF REPORT: 05/24/2021.

    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 GANTRY MOTION CONTINUED AFTER THE BUTTONS WERE RELEASED ON THE HAND CONTROLLER. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT AND IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769462 SKYLIGHT IMAGING SYSTEM SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SKYLIGHT-2160-3001A

    Patients

    Seq Age Sex Outcome Treatment
    1