BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION ONE PRISM

    MDR report key: 10740941 · Received October 27, 2020

    Report

    Report Number
    10740941
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 24, 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 ABORTED SCAN DURING ACQUISITION AND THEN MOVED SFOV UNEXPECTEDLY CAUSING TWO REPEATS TO BE DONE ON THE PATIENT. THIS HAPPENED AGAIN AND BIOMED HAS BEEN NOTIFIED, HOWEVER, THE PART IS BACK ORDERED AND CANNOT BE FIXED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207030 AQUILION ONE PRISM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS CORPORATION PRISM

    Patients

    Seq Age Sex Outcome Treatment
    1