BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE ONCOLOGY

    MDR report key: 8723200 · Received June 21, 2019

    Report

    Report Number
    1525965-2019-00024
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    May 30, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PLANNED MAINTENANCE (PM), THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A COVER MISALIGNMENT. UPON FURTHER INVESTIGATION, THE FSE FOUND THE METAL SUPPORT ON THE INSIDE FRONT COVER, AT THE TOP, SEPARATED FROM THE FRONT COVER AT BOTH ENDS OF THE METAL SUPPORT BAR. IT WAS DETERMINED THE COVER NEEDED TO BE REPLACED. THIS ISSUE WAS REVIEWED BY ENGINEERING. BASED ON ENGINEERING¿S INVESTIGATION RESULTS, THE SEPARATION AREA WAS LOCATED AT BOTH SHORT ENDS OF THE METAL SUPPORT BAR. THE METAL SUPPORT BAR INSIDE THE TOP OF THE FRONT COVER WAS BONDED WELL WITH THE FIBERGLASS RESIN ALONG THE ENTIRE LENGTH OF THE METAL BAR FIRMLY. THE SEPARATION AT THE SHORT ENDS OF THE METAL SUPPORT BAR WILL NOT AFFECT THE STRENGTH AND STIFFNESS OF THE FRONT COVER ASSEMBLY. THIS MALFUNCTION WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO NO LONGER BE A REPORTABLE EVENT. THE PROBABLE CAUSE IS WEAR AND TEAR OF THE METAL BAR. THE FSE REPLACED THE FRONT COVER AND THE SYSTEM IS FUNCTIONAL AND IS IN CLINICAL USE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE 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. (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 PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE GANTRY FRONT COVER WAS SEPARATING AT THE TOP HINGE. THIS ISSUE 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
    515777 BRILLIANCE BIG BORE ONCOLOGY COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1