BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON AQUILION ONE

    MDR report key: 15804445 · Received November 16, 2022

    Report

    Report Number
    15804445
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 8, 2022
    Manufacturer
    CANON MEDICAL SYSTEM, USA, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    YOUNG TRAUMA PATIENT (HIT HEAD ON GROUND AND VOMITING WITH HEADACHES) TO HAVE HEAD SCAN WITHOUT CONTRAST AND DURING RECON OF VOLUME HEAD, THE SCANNER FROZE. TEAM MEMBER HAD TO RESTART THE SCANNER AND THIS DELAYED THE IMAGES BEING READ IN A TIMELY MANNER. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829529 CANON AQUILION ONE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEM, USA, INC. TSC-301C

    Patients

    Seq Age Sex Outcome Treatment
    1 2920 DA Female