BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON AQUILION PRIME

    MDR report key: 12040163 · Received June 22, 2021

    Report

    Report Number
    12040163
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 15, 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

    SCANNER WOULD NOT BUILD IMAGES AFTER SCANNING THE PATIENT, SO IMAGES WERE NOT VISIBLE AT ALL. THIS RESULTED IN A THREE HOUR PATIENT CARE DELAY ON A TRAUMA PROTOCOL WHILE THIS WAS WORKED ON. EQUIPMENT HAS HAD PROBLEMS LIKE THIS BEFORE WHICH WERE LOOKED INTO BY BIOMED LAST WEEK, BUT ARE CLEARLY UNRESOLVED. PATIENT WAS VERY ANGRY PER PROVIDER. WAIT TIME WAS GREATER THAN 3 HOURS FOR RESULTS. PATIENT DISCHARGED HOME WITH FOLLOW UP WITH NEUROSURGERY. SENT HTM FOR FOLLOW UP. CANON WAS NOTIFIED BY CT MANAGER TODAY. RADIOLOGY RSA TEAM ADDED TO DISCUSSION. UPDATE FROM RADIOLOGY: EVENT REVIEWED, SERVICE AND CT TECHNOLOGISTS WERE UNABLE TO DUPLICATE SLOWNESS. MULTIPLE TESTS WERE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940432 CANON AQUILION PRIME SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEM, USA, INC. CGS-72A/2B

    Patients

    Seq Age Sex Outcome Treatment
    1