BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3801694 · Received April 25, 2014

    Report

    Report Number
    1525965-2014-00083
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2014 THE PHILIPS FSE REPORTED THAT INSTRUCTIONS FOR USE (IFU) THAT IS LOADED ON THE HOST COMPUTER HAS DIFFERENT QA VALUES THAN THE IFU FOR 2.6 SOFTWARE (SW) SYSTEMS THAT IS LOCATED ON INCENTER. THERE WAS NO REPORT OF ANY IMAGE MISINTERPRETATION AS A RESULT OF THIS EVENT. THE CONSOLE SW VERSION ON THE SYSTEM IS 2.6.2.21004. THE IFU THAT IS LOADED ON THE HOST COMPUTER IS (B)(4). THE FSE STATED THAT THE IFU THAT IS LOADED ON THE HOST COMPUTER DISPLAYS A TEFLON PIN TOLERANCE OF 890 +- 50 WHILE THE IFU 459800034631 HAS A TEFLON PIN TOLERANCE OF 930 +- 30. ALSO THE STANDARD DEVIATION ON THE IFU FROM THE HOST COMPUTER DISPLAYS A VALUE OF 11.9 +- 1.2 WHILE ON THE IFU 459800034631 IS DISPLAYING A VALUE OF 12.8 +- 1.6. THE PHILIPS FSE CALIBRATED THE SYSTEM FOLLOWING THE IFU 459800034631. A SENIOR SW CONFIGURATION ENGINEER WAS CONSULTED REGARDING THIS ISSUE. IT WAS CONFIRMED THAT THE ONLINE HELP CD VERSION 2.6.1.1047 WHICH INCLUDED IFU VERSION 459800034631 SHOULD HAVE BEEN INSTALLED ON THE SYSTEM VIA FCO 72800517. SOFTWARE CONFIGURATION MANUAL HAS INSTRUCTIONS TO LOAD ONLINE HELP CD V2.6.1.1047. FCO 72800517 WAS INSTALLED ON THIS SYSTEM (B)(4) 2011. ENGINEERING INVESTIGATION INTO THIS ISSUE DETERMINED THAT BASED ON THE INFORMATION PROVIDED THE PROBLEM IS THAT THERE ARE CONFLICTING VALUES LISTED FOR THE SAME MEASUREMENT IN 2 SEPARATE USER INSTRUCTIONS FOR USE. UPON REVIEW THE 2 USER IFU'S THAT WERE CITED WERE NOT BOTH INTENDED FOR THE SCANNER AND SOFTWARE VERSION BEING USED. IFU 453567434601 WAS APPROPRIATE FOR THE SCANNER RUNNING SOFTWARE VERSIONS PRIOR TO 2.6.1 AND IFU 459800034631 WAS INTENDED FOR SCANNERS RUNNING SOFTWARE VERSION 2.6.1 WHICH MEANS THAT THE MEASUREMENTS PROVIDED COULD HAVE CHANGED DUE TO CHANGES INCLUDED IN THE NEW SOFTWARE VERSION. SOFTWARE VERSION 2.6.1 INCLUDES A NEW RECONSTRUCTION ALGORITHM KNOWN AS CLEAR RAY THAT COULD EXPLAIN THE DIFFERENT SPECIFICATIONS FOR THE SAME MEASUREMENT ON THE SAME SCANNER. CONSULTATION WITH THE SOFTWARE GROUP DETERMINED THAT IFU 453567434601 WOULD REMAIN ON THE SYSTEM IF THE ONLINE HELP CD (2.6.1.1047) WAS NOT INSTALLED AFTER THE 1 CLICK INSTALLATION CD FOR VERSION 2.6.1. AS INSTRUCTED IN FCO 72800517. THE ONLINE HELP CD UPDATES THE MANUAL VERSION FROM IFU 453567434601 TO IFU 459800034631. THIS IS THE MOST LIKELY CAUSE OF THE INCORRECT MANUAL BEING PRESENT ON THE SCANNER. ON (B)(4) 2015 THE PHILIPS FSE CONFIRMED THAT THE CORRECT ONLINE HELP CD VERSION 2.6.1.1047 WAS INSTALLED ON THE SYSTEM. THE USER IFU'S LOADED ON THE HOST COMPUTER ARE NOW LOADED WITH THE CORRECT DOCUMENTATION FOR THE SOFTWARE VERSION THE SYSTEM IS RUNNING. IF THE DAILY QUALITY ASSURANCE VALUES ARE INCORRECT, THERE IS POTENTIAL THAT THE DISPLAYED CT NUMBERS IN PATIENT IMAGES ARE INACCURATE, WHICH COULD RESULT IN MISINTERPRETATION. THE OVERALL RISK IS BASED ON ENGINEER'S INVESTIGATION AND ACCORDING TO THE RISK ASSESSMENT THIS REPORTED EVENT WAS DETERMINED TO BE OF ACCEPTABLE RISK. IT HAS BEEN CONCLUDED THAT IF THIS EVENT WERE TO RECUR IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. DAILY AND MONTHLY IMAGE QUALITY CHECKS BY OPERATOR IN INSTRUCTION FOR USE. 9.3.2 B PROPER CALIBRATION INSTRUCTIONS. THE PHILIPS FSE CONFIRMED THAT THE CORRECT ONLINE HELP CD VERSION 2.6.1.1047 WAS INSTALLED ON THE SYSTEM. THE ROOT CAUSE OF THIS EVENT IS THAT WHEN FCO 72800517 WAS INSTALLED ON THE SYSTEM, ONLINE HELP CD VERSION 2.6.1.1047 WAS NOT INSTALLED AS INSTRUCTED IN THE FCO DOCUMENTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IN THIS CASE THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE CURRENT INSTRUCTIONS FOR USE (IFU) ON THE HOST COMPUTER DOES NOT HAVE THE CURRENT 2.6 SOFTWARE AVERAGE AND STANDARD DEVIATION ABSORPTION VALUES FOR THE TEFLON PIN FOR THE QUALITY ASSURANCE CHECKS. FSE CONFIRMED THAT NO RESCAN WAR REQUIRED AND DOES NOT EFFECT IMAGE QUALITY. THERE WAS NO HARM TO PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250318 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1