BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON CT SCANNER

    MDR report key: 8119795 · Received November 30, 2018

    Report

    Report Number
    8119795
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    CANON MEDICAL SYSTEMS USA, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS FACILITY OWNS A 16 SLICE CT MACHINE THAT'S MADE BY TOSHIBA (TOSHIBA WAS RECENTLY BOUGHT OUT BY CANON MEDICAL). THE ISSUE I'M EXPERIENCING IS THAT WE'VE HAD A SERVICE CONTRACT ON THIS DEVICE WITH TOSHIBA SINCE WE'VE HAD THIS MACHINE. IN OCTOBER WE DECIDED TO TAKE THE DEVICE OFF CONTRACT AND MANAGE THE SUPPORT IN-HOUSE. WHEN WE DECIDED TO DO THIS TOSHIBA REMOVED THE INNERVISION AND SUGGESTED THAT WE PURCHASE IT FROM THEM TO REMAIN SECURE. THE INNERVISION IS A PROGRAM THAT PROTECTS THE CT FROM CYBER THREATS. TO SIMPLIFY THIS SITUATION LETS SAY YOU BOUGHT A CAR FROM THE DEALERSHIP AND PURCHASED THE EXTENDED THE WARRANTY. WHEN THE WARRANTY RENEWAL WAS DUE YOU DECIDED TO NOT RENEW. THE DEALER THEN RESPONDS BY SAYING SINCE YOU DIDN'T RENEW WE ARE NOW REMOVING THE SEATBELTS AND AIRBAGS AND THEN OFFERS THEM FOR SALE THROUGH ANOTHER PACKAGE. OVERALL I FEEL SECURITY AND ITS ENTIRETY SHOULD BE PART OF THE SYSTEM AND ITS COST SHOULD HAVE BEEN BUILT IN ITS INITIAL PRICE, IT SHOULD NOT BE COMPROMISED, THESE TACTICS BY THE VENDOR CAN AFFECT PATIENT CARE IF SYSTEMS DO GET INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961101 CANON CT SCANNER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK CANON MEDICAL SYSTEMS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA