BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLIGHT IMAGING SYSTEM

    MDR report key: 11871453 · Received May 24, 2021

    Report

    Report Number
    3015777306-2021-10005
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 26, 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 · 0

    THE ISSUE REPORTED WAS THAT UNCOMMANDED DETECTOR MOTION OCCURRED AFTER COMPLETION OF A GANTRY CALIBRATION. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THIS OCCURRED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE AND CONFIRM THE REPORTED ISSUE. THE FSE REPORTED THAT THE CUSTOMER HAD SUCCESSFULLY COMPLETED A GANTRY CALIBRATION AND THEN BEGAN TO LOWER THE TABLE WITH THE HAND CONTROLLER. AT THIS TIME THE CUSTOMER NOTICED THE SOUND OF THE GANTRY BRAKE RELAYS CLICKING (TWO CLICKS) THEN NOTICED DETECTOR 2 LOWER ABOUT 3/4 TO ONE INCH. THE FSE CONFIRMED THAT THERE WAS NOT A PATIENT ON THE TABLE AT THE TIME OF THIS ISSUE. AFTER THIS ISSUE OCCURRED, THE CUSTOMER CONTINUED USING THE SYSTEM FOR THE REST OF THE DAY WITHOUT ISSUES. THIS ISSUE ONLY OCCURRED ONCE, AND NO CORRECTIONS WERE MADE TO THE SYSTEM BY THE FSE. THE FSE COLLECTED SYSTEM LOG FILES FOR FURTHER INVESTIGATION. PHILIPS ENGINEERING REVIEWED ALL AVAILABLE INFORMATION, INCLUDING LOG FILES AND CONCLUDED THE FOLLOWING: TOUCHSCREEN LOG FILES CONFIRMS THE DETECTOR 2 MOVEMENT OF 4MM OCCURRED AFTER HAND CONTROLLER USAGE AS REPORTED BY THE USER. IT IS UNCLEAR WHETHER THE GANTRY SOFTWARE INITIATED THE MOTION, HOWEVER, THE SYSTEM MOTION HALTED ON ITS OWN AT MOVING 4MM. FURTHERMORE, THE SYSTEM IS EQUIPPED WITH EMERGENCY STOP BUTTONS AND COLLISION DETECTION 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. THE PROBABLE CAUSE IS THE PHYSICAL HAND CONTROLLER WAS FAULTY THAT TRIGGERED TWO MOTIONS WHEN THE TABLE MOTION WAS COMMANDED. BASED ON INVESTIGATION CONCLUSION, THIS ISSUE IS NOT REPORTABLE. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4). DATE OF REPORT: 20210624. HEALTH IMPACT CODE: C50912; NO PATIENT INVOLVEMENT WHEN THE ADVERSE EVENT OCCURRED (FOR EXAMPLE HAPPENED DURING SET-UP OR CLEANING).

    Additional Manufacturer Narrative · 1

    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: COMPLAINT PR# (B)(4). DATE OF REPORT: 20210524.

    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 UNCOMMANDED DETECTOR MOTION OCCURRED AFTER COMPLETION A GANTRY CALIBRATION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT AND IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766085 SKYLIGHT IMAGING SYSTEM SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SKYLIGHT-2160-3001A

    Patients

    Seq Age Sex Outcome Treatment
    1