BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON AQUILION PRIME

    MDR report key: 12040165 · Received June 22, 2021

    Report

    Report Number
    12040165
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 17, 2021
    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

    Narratives

    Description of Event or Problem · 1

    WE WERE SCANNING THE PATIENT FROM THE ER AND WE GOT THROUGH THE SCOUT IMAGES, S&V, AND FLUSHED SALINE. ONCE WE WERE READY TO INJECT CONTRAST AND START THE ACTUAL SCAN, THE SCAN STARTING LIGHT WOULD NOT TURN ON. WE EXITED OUT OF THE SCAN TO TRY TO GO BACK INTO IT AND IT DID NOT WORK. THEN WE TURNED THE GANTRY OFF AND THEN THE WHOLE MACHINE ITSELF. WHEN IT TURNED BACK ON, WE WERE ABLE TO SCAN THE PATIENT AND FINISH THE SCAN. THIS WHOLE PROCESS TOOK ABOUT 20-30 OF THE PATIENT BEING ON THE TABLE, WAITING TO BE SCANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940434 CANON AQUILION PRIME SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEM, USA, INC. CGS-72A/2B

    Patients

    Seq Age Sex Outcome Treatment
    1