BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW

    MDR report key: 10209826 · Received June 29, 2020

    Report

    Report Number
    3015777306-2020-00006
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    April 3, 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 A PREVENTATIVE MAINTENANCE (PM) SERVICE EVENT, THE FLAT PANEL DETECTOR (FPD) LINKAGE WAS FOUND TO BE BENT. THE FSE EVALUATED THE DEVICE AND DETERMINED THAT IT WAS NOT POSSIBLE TO STOW THE FPD BECAUSE THE HANDLE COULD NOT GO COMPLETELY AWAY. THE FPD WAS ABLE TO BE LOCKED SECURELY IN THE DEPLOYED POSITION. THE FSE DETERMINED THAT THE LINKAGE WAS BENT AND REPLACED THE LINKAGE TO RESOLVE THE ISSUE. 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 THE SITE: THE FSE REPLACED THE LINKAGE PIN TO RESOLVE THE ISSUE. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    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. 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
    668932 BRIGHTVIEW SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT

    Patients

    Seq Age Sex Outcome Treatment
    1