BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON AQUILION ONE

    MDR report key: 15804417 · Received November 16, 2022

    Report

    Report Number
    15804417
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    November 2, 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

    A CT ANGIOGRAM (CTA) OF THE THORACOABDOMINAL AORTA WAS BEING PERFORMED AND DURING THE VOLUME OF THE HEART, THE SCANNER FROZE. ULTIMATELY, CARDIAC IMAGES WERE LOST. UP TO THIS POINT, WHEN THEY HAVE HAD ISSUES WITH THE SCANNER FREEZING DURING THE ANGIO OR VOLUME PHASE OF VARIOUS STUDIES, THEY HAVE BEEN ABLE TO SALVAGE THE STUDY. IMAGES WERE LOST IN THIS CASE. (NO PATIENT INJURY.) ESCALATED TO SERVICE MANAGER AT CANON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783075 CANON AQUILION ONE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEM, USA, INC. TSC-301C

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Male