BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCENARIA PHASE 3 CT SYSTEM

    MDR report key: 8599328 · Received May 10, 2019

    Report

    Report Number
    8030405-2019-00003
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 10, 2019
    Manufacturer
    HITACHI HEALTHCARE AMERICAS
    Product Code
    JAK
    PMA / PMN Number
    K150595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCENARIA PHASE 3 IS A CT SYSTEM. (B)(4) RECEIVED A COMPLAINT ON (B)(6) 2019 REGARDING THE SCENARIA PHASE 3. THE SITE REPORTED AN UNEXPECTED DETACHMENT AND EJECTION OF A CABLE. THE CABLE IS LOCATED WITHIN THE GANTRY AND SECURED IN PLACE BY MANUAL TIGHTENING OF THE CONNECTION POINT AND MULTIPLE ZIP TIES. THE PATIENT WAS REMOVED FROM THE BORE OF THE SYSTEM SO NO ONE WAS INJURED DURING THIS INCIDENT. (B)(4) FIELD SERVICE ENGINEER WAS DISPATCHED ONSITE. THEY ANALYZED THE SYSTEM AND REPLACED THE NECESSARY COMPONENTS. THE CABLE AND ASSOCIATED PARTS WERE ALSO ANALYZED. THE ROOT CAUSE OF THE PROBLEM CANNOT BE CONCLUDED DEFINITIVELY. THE ROOT CAUSE CAN BE TRACED BACK TO POSSIBLE IMPROPER/FAILURE TO MANUALLY TIGHTEN THE CONNECTION OF THE CABLE TO THE SYSTEM OR POSSIBLE IMPROPER/FAILURE TO PROPERLY SECURE THE CABLE WITH TIES.

    Description of Event or Problem · 1

    ON (B)(6) 2019, (B)(4) RECEIVED A COMPLAINT REGARDING THE S5012, SCENARIA CT SYSTEM. THE SITE REPORTED A "CLUNKING" SOUND FROM THE GANTRY DURING A BIOPSY PROCEDURE. THE GANTRY WAS SPINNING AND THE X-RAY WINDOW WAS PULLED LOOSE FROM THE SYSTEM. THE CABLE CAUGHT ON THE X-RAY WINDOW AND CREATED A GAP LARGE ENOUGH FOR THE CABLE TO BE EJECTED FROM THE SYSTEM. THE TECHNICIAN PERFORMED AN EMERGENCY RELEASE OF THE TABLE WHEN SHE HEARD THE SOUND SO THE PATIENT WAS OUT OF THE BORE WHEN THE CABLE WAS EJECTED. THE TECHNICIAN CONFIRMED THE CABLE DID NOT HURT ANYONE DURING THE INCIDENT. THE BIOPSY PROCEDURE WAS DELAYED AND FINISHED LATER THAT DAY ON A DIFFERENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392361 SCENARIA PHASE 3 CT SYSTEM SCENARIA PHASE 3 CT SYSTEM JAK HITACHI HEALTHCARE AMERICAS SCENARIA PHASE 3 CT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other