BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION ONE (VISION)

    MDR report key: 8009136 · Received October 25, 2018

    Report

    Report Number
    MW5080842
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 23, 2018
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CT SCANNER ERROR PREVENTED EXPOSURE OR IONIZING RADIATION, CONTRIBUTING TO AN INJECTION OF IV CONTRAST WITHOUT DIAGNOSTIC IMAGING. ON (B)(6) 2018 PATIENT #(B)(6) ARRIVED IN CT SCAN AS AN OUTPATIENT TO RECEIVE A CT SCAN OF THE HEART WITHOUT CORONARIES WITH IV CONTRAST. THE PROTOCOL FOR THE SCAN INCLUDES FIRST A NON-CONTRAST PHASE HEART CT, SECOND A BOLUS TRACKING PHASE FOR TRACKING CONTRAST AT THE LEVEL OF THE HEART, AND THIRD A FULL CONTRAST CT OF THE CHEST ABDOMEN AND PELVIS. THE PATIENT UNDERWENT THE FIRST PHASE OF THEIR SCAN WHICH WAS A NON-CONTRAST CT SCAN OF THE HEART WITHOUT INCIDENT. THE TECHNOLOGIST THEN LOADED 70CC'S OF IV CONTRAST (OMNIPAQUE 350) INTO THE POWER INJECTOR AND INITIATED THE CONTRAST PORTION OF THE EXAMINATION. THE SECOND PHASE BEGAN NORMALLY WITH CONTRAST FILLING THE HEART, AND TRIGGERING THE CONTRAST IMAGING PHASE OF THE EXAMINATION. THE SCANNER MOVED THE PATIENT TO THE BEGINNING OF THE SCAN RANGE. BEFORE ACQUIRING ANY IMAGES, THE MACHINE'S COMPUTER DISPLAYED THE FOLLOWING ERROR ON THE SCANNER "SCANNER ERROR. PLEASE REBOOT SYSTEM". THE ERROR PREVENTED THE TECHNOLOGIST FROM SCANNING THE PATIENT AND CAPTURING THE CONTRAST PHASE OF THE EXAMINATION. THE SCANNER DID NOT ALLOW THE TECHNOLOGIST TO CLEAR THE ERROR WITHOUT A FULL REBOOT OF THE CT SCANNER. THE 70CC'S OF CONTRAST WERE ADMINISTERED TO THE PATIENT WITHOUT ANY IMAGES BEING ACQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844304 AQUILION ONE (VISION) SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other