BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION ONE PRISM

    MDR report key: 10733573 · Received October 26, 2020

    Report

    Report Number
    10733573
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 28, 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

    DURING THE MIDDLE OF THE SCAN, IT ABORTED. TRIED TO RESCAN THE PART THAT WAS NOT YET IMAGED AND IT ABORTED RIGHT AWAY. WE ATTEMPTED TO SCAN AGAIN MULTIPLE TIMES BUT EVERY TIME WE TRIED, IT ABORTED AGAIN. WE EVENTUALLY GOT IT TO SCAN THE REST OF THE PATIENT. PART FOR SCANNER SHOULD BE COMING IN BUT WE DO NOT KNOW WHAT TIME IT WILL BE REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202358 AQUILION ONE PRISM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS CORPORATION PRISM CT

    Patients

    Seq Age Sex Outcome Treatment
    1