BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION ONE PRISM

    MDR report key: 10733385 · Received October 26, 2020

    Report

    Report Number
    10733385
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 9, 2020
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SCANNER MALFUNCTIONED AND CAUSED A TUBE ARC ON THE SCAN. IMAGE QUALITY WAS SIGNIFICANTLY DECREASED AND THE PATIENT HAD TO BE RESCANNED AND DOUBLE RADIATED. MANY TUBE ARCS HAVE OCCURRED ON THE SCANNER AND CONTINUED TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197858 AQUILION ONE PRISM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS CORPORATION PRISM CT

    Patients

    Seq Age Sex Outcome Treatment
    1