BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM SENSATION 64 / CARDIAC 64

    MDR report key: 3792073 · Received April 22, 2014

    Report

    Report Number
    3792073
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CT01 TABLE TOP MOVED INTO GANTRY DURING A CT GUIDED PROCEDURE. THE EMERGENCY STOP BUTTON WAS PRESSED IMMEDIATELY. NO PATIENT HARM. STAFF REPORTED THE TABLE MOVED BY ITSELF WITHOUT STAFF INITIATING TABLE TOP MOVEMENT.THIS EVENT OCCURRED TWICE WITHIN APPROXIMATELY 20 DAYS. THE EVENT TYPE WAS THE SAME. A TOTAL OF TWO CT SCANNERS ARE INVOLVED. NO PATIENTS OR STAFF WERE INJURED IN EITHER EVENT.THE MANUFACTURER WAS NOTIFIED WITH EACH EVENT AND SENT A REP OUT TO INSPECT THE DEVICE. WITH THE FIRST EVENT, THE MANUFACTURER WAS UNABLE TO REPRODUCE THE PROBLEM AND THE DEVICE PASSED INSPECTION; IT WAS RETURNED TO SERVICE. WITH THE SECOND EVENT, THE LEFT AND RIGHT GANTRY CONTROL PANELS WERE REPLACED BY THE MANUFACTURER. THE DEVICE HAS BEEN RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243724 SOMATOM SENSATION 64 / CARDIAC 64 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS MEDICAL SOLUTIONS 7454890 *
    243725 SOMATOM SENSATION 64 / CARDIAC 64 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS MEDICAL SOLUTIONS 8377520 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR