BEUDAMED
    FDA Adverse Event Summary report: N

    ICT

    MDR report key: 3688043 · Received March 12, 2014

    Report

    Report Number
    1525965-2014-00047
    Date Received
    March 12, 2014
    Report Date
    February 11, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY UTILIZED ITERATIVE MODEL RECONSTRUCTION (IMR) ON CARDIAC CALCIUM SCORE PROCEDURES, THE CALCIUM SCORE RESULTS ARE SIGNIFICANTLY DIFFERENT COMPARED TO THE RESULTS WHEN FILTERED BACK PROJECTION (FBP) AND IDOSE ARE UTILIZED. A PHILIPS TECHNICAL TRAINER CONFIRMED THIS ISSUE WAS RECOGNIZED BY THE TRAINED PROFESSIONAL AND THERE WAS NO MISINTERPRETATION, MISTREATMENT, OR RESCAN OF A PATIENT. THE CUSTOMER HAS DIFFERENT TREATMENT PLANS FOR PATIENTS BASED ON THE CALCIUM SCORE RESULTS AND WHEN IMR IS UTILIZED IT CREATES AN UNEXPECTED HIGHER SCORE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147795 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1