BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 7250820 · Received February 8, 2018

    Report

    Report Number
    1525965-2018-00340
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Report Date
    October 26, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A RING ARTIFACT IN SCAN DATA AND A MONITOR WAS NOT WORKING (ADDRESSED IN PR 8761230). A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS NO HARM TO A PATIENT AND NO REPORT OF MISREPRESENTATION AND/OR MISTREATMENT AS A RESULT OF THIS ISSUE. THE FSE CONFIRMED THAT RING ARTIFACTS WERE PRESENT ON SCAN IMAGES. THE FSE VISUALLY INSPECTED THE SYSTEM AND FOUND A FAILED COMPENSATOR IN THE A-PLANE COLLIMATOR. THE FSE REPLACED THE COMPENSATOR TO RESOLVE THE ISSUE, AND THE SYSTEM WAS RETURNED TO CLINICAL USE. THIS ISSUE HAS BEEN DETERMINED NOT 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. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4)

    Description of Event or Problem · 1

    ENGINEERING ANALYSIS CONCLUDED THAT THIS EVENT HAS THE POTENTIAL TO RESULT IN IMAGE MISINTERPRETATION DUE TO AN ARTIFACT FROM A DEGRADED COMPENSATOR WITHIN THE COLLIMATOR. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101492 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1