BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 10204456 · Received June 28, 2020

    Report

    Report Number
    3015777306-2020-00003
    Event Type
    Malfunction
    Date Received
    June 28, 2020
    Date of Event
    April 20, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    PMA / PMN Number
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) INSPECTION ON A BRIGHTVIEW XCT THE FLAT PANEL DETECTOR (FPD) LINKAGE WAS BENT. THE FSE REPORTED THAT DURING THE PM INSPECTION, HE EVALUATED THE MECHANICAL PARTS OF THE SYSTEM, AND SEEN THAT THE HANDLE OF THE FLAT PANEL WAS NOT EASY TO MOVE (OPEN/CLOSE). THE FSE MEASURED THE HANDLE WITH A PRESSURE GAUGE WHICH MEASURED 10.5 LBS, THE MEASUREMENT SHOULD BE BETWEEN 11-13.2LBS. THE FSE ALLEGED THIS WAS DUE TO THE AXIS BEING SLIGHTLY BENT FROM FORCE BY THE USER WHEN HE STOWED OR DEPLOYED THE FLAT PANEL. THE ISSUE WAS SUBMITTED TO PHILIPS ENGINEERING FOR FURTHER INVESTIGATION WHICH CONCLUDED THE FOLLOWING: THE MECHANISM DESIGN HAS SUFFICIENT LIFE UNDER NORMAL USAGE CONDITION I.E. FLAT PANEL DETECTOR ALIGNED AND APPLICATION OF 12LBS AT THE HANDLE. UNDER REPEATED FORESEEABLE MISUSE, THE PART WILL UNDERGO BENDING (DUE TO PROGRESSIVE LOADING). THE FORCE REQUIRED TO OPERATE THE HANDLE VARIES WHEN THE PART BENDS (DUE TO PROGRESSIVE LOADING) AND CHECKS IN PLANNED MAINTENANCE (EVERY SIX MONTHS) ARE INTENDED TO IDENTIFY THE ISSUE AT THIS STAGE. THE OPERATOR CAN ALSO IDENTIFY THIS INCREASE IN FORCE REQUIRED. THIS ISSUE WAS FOUND DURING PM AND NO HARM HAS BEEN REPORTED. PER THE INSTRUCTION FOR USE (IFU) MANUAL: ¿EXTEND THE FPD AND THE ARM THAT SUPPORTS IT OUT TOWARDS YOU 90 DEGREES SO THAT THE ENTIRE ASSEMBLY IS PERPENDICULAR TO THE GANTRY¿. THIS ENSURES THE ALIGNMENT OF LOCKING PIN WITH THE LOCKING HOLE AND HELPS USER TO APPLY INTENDED FORCE TO LOCK THE HANDLE IN PLACE. THE FORCE REQUIRED TO OPERATE THE HANDLE INCREASES WHEN THE PART BENDS AND INSPECTIONS IN PLANNED MAINTENANCE ARE INTENDED TO IDENTIFY ISSUE AT THIS STAGE AS IN THIS CASE. THE PROBABLE CAUSE OF THIS EVENT IS EXCESSIVE FORCE PLACED ON THE FPD WHEN STOWING OR DEPLOYING. CORRECTION AT SITE: THE LINKAGE PIN WILL BE REPLACED AT THE NEXT PLANNED PREVENTATIVE MAINTENANCE.

    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. A PHILIPS FIELD SERVICE REPORTED THE XCT FLAT PANEL LINKAGE WAS BENT DUE TO IMPROPER USER HANDLING. THIS WAS IDENTIFIED DURING A PREVENTATIVE MAINTENANCE EVALUATION. THERE WAS NO HARM. ENGINEERING'S INITIAL INVESTIGATION SUGGESTS RISK IS NOT REDUCED AS FAR AS POSSIBLE, HENCE THE RISK IS DETERMINED TO BE UNACCEPTABLE. BASED ON THE ADDITIONAL INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE 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. A PHILIPS FIELD SERVICE REPORTED THE XCT FLAT PANEL LINKAGE WAS BENT DUE TO IMPROPER USER HANDLING. ENGINEERING'S INITIAL INVESTIGATION SUGGESTS RISK IS NOT REDUCED AS FAR AS POSSIBLE, HENCE THE RISK IS DETERMINED TO BE UNACCEPTABLE. BASED ON THE ADDITIONAL INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668430 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1