BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.6 PINNACLE 3 SW

    MDR report key: 3633823 · Received January 18, 2014

    Report

    Report Number
    3004022368-2013-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Report Date
    December 2, 2013
    Manufacturer
    PHILIPS NUCLEAR MEDICINE, INC
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PINNACLE BUG CAUSES DENSITY OVERRIDDEN CONTOURS TO ACQUIRE UNREALISTICALLY HIGH DENSITY VALUES IN THE RANGE OF THOUSANDS OF GICC. THE FOLLOWING IS AN EXAMPLE OF HOW THE ERROR IS CAUSED. WE SEE A H&N PT WITH DENTAL FILLINGS OVERRIDDEN TO 11 G/CC AND SOFT TISSUE ARTIFACTS OVERRIDDEN TO 1 G/CC. THE DOSE IS CALCULATED. WHEN PERFORMING A MOUSE OVER WITH THE CT#DOSE TOOL OVER THE DENTAL FILLINGS, THE DENSITY IS CORRECTLY REPORTED AS 11:00 G/CC. WHEN YOU TRY TO MODIFY THE CONTOURS FOR EITHER THE DENTAL FILLINGS OR ARTIFACTS WITHOUT TURNING OFF THE DENSITY OVERRIDE, THE DENTAL FILLINGS ARE NOW REPORTED BY THE CT#DOSE TOOL AS HAVING A DENSITY OF 14877 G/CC. THIS 14877 IS NUMERICALLY IDENTICAL TO THE CT# THAT CORRESPONDS TO 11:00 G/CC. THE ROOT CAUSE OF THIS ISSUE IS A SOFTWARE DEFECT. THE INVESTIGATION REVEALED AN ACCEPTABLE RISK, AS PER THE MFR'S ASSESSMENT AND NO CUSTOMER MITIGATION IS WARRANTED TO PREVENT A REOCCURRENCE. THE SOFTWARE WILL BE UPDATED WHEN THE NEXT REVISION IS RELEASED, CURRENTLY SCHEDULED FOR (B)(4) 2014. THERE IS NO UNFAVORABLE TREND AT THIS TIME. THERE HAVE BEEN ONLY THREE REPORTED CASES OF THIS ISSUE. ALSO, AT THE TIME OF THE SUPPORT CALL THE PRODUCT SUPPORT ENGINEER PROVIDED AN EMAIL TO THE CUSTOMER EXPLAINING THAT THE ISSUE IS A KNOWN DEFECT. THE CUSTOMER WAS PROVIDED THE FOLLOWING WORK AROUND EXIT THE PLAN THEN REOPEN THE PLAN AND THE DENSITY WILL BE GOOD AGAIN.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT THEY ARE SEEING UNREALISTICALLY HIGH DENSITY READOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46299 9.6 PINNACLE 3 SW MUJ PHILIPS NUCLEAR MEDICINE, INC 459800235871

    Patients

    Seq Age Sex Outcome Treatment
    1