BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON AQUILION ONE

    MDR report key: 15804485 · Received November 16, 2022

    Report

    Report Number
    15804485
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 19, 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

    THE CT SCANNER WENT DOWN WHILE PERFORMING A STROKE SERIES SCAN. THE SCANNER FROZE DURING A PIVOTAL MOMENT IN THE SERIES. THE SCANNER THEN HAD TO BE REBOOTED WHICH DELAYED THE IMAGES BEING SENT AND READ FOR THE PATIENT. PATIENT WAS MOVED TO OTHER ROOM TO QUICKLY COMPLETE SCANS. THERE HAVE BEEN RECENT ISSUES WITH THE SCANNER MALFUNCTIONING DURING ANGIO STUDIES AND VOLUME STUDIES. ADDITIONAL EVENTS WITH FREEZING SCANNER INCLUDE (BUT NOT REPORTED TO QUALITY AND SO NO ADDITIONAL INFORMATION IS AVAILABLE). HEAD AND C-SPINE W/O.PELVIS W/O. ERROR MESSAGE WAS "RTM ERROR", RECON OF HIP. ERROR MESSAGE WAS "MPR NOT WORKING."ANGIO PORTION OF DISSECTION; HEAD (SCANNER FROZE WHEN PULLING PATIENT UP ON WORKLIST; STROKE (AFTER PERFUSION, BEFORE CAROTID); TRAUMA C/A/P WITH CONTRAST; DURING QC, ERROR IN RECON SEQUENCE. ALL OF THESE FAILURES REQUIRE A REBOOT WHICH LEADS TO A DELAY IN CARE AND ADDITIONAL STEPS FOR THE TECHNICAL TEAM. CANON HAS ESCALATED THIS TO BOTH THEIR NATIONAL PARTS TEAM AND NATIONAL SERVICE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352730 CANON AQUILION ONE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEM, USA, INC. TSC-301C

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA Female