BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM DEFINITION FLASH

    MDR report key: 2973694 · Received February 22, 2013

    Report

    Report Number
    2240869-2013-00748
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    JAK
    PMA / PMN Number
    K121072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PANEL KEY PAD (PART # (B)(4)2) WAS REPLACED AND THE SYSTEM IS FULLY OPERATIONAL. THIS OCCURRENCE IS THE FIRST INCIDENT INVOLVING A PATIENT AND COMPLETE UNINTENDED MOVEMENT. SIEMENS INVESTIGATION OF THE REPORTED INCIDENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETE OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO THIS INCIDENT AND THE SUBSEQUENT INVESTIGATION, SIEMENS HAS DETERMINED BASED ON THE LOGFILES PROVIDED BY THE LOCAL CUSTOMER SERVICE ENGINEER THAT THE UNINTENDED TABLE MOVEMENT WAS DUE TO BUTTONS ON THE GANTRY KEY PANEL STICKING UNDERNEATH THE GANTRY COVER. SIEMENS HAS RECOMMENDED THAT THE GANTRY COVER BE REPLACED. THE CUSTOMER REPLACED THE GANTRY COVER ON (B)(4) 2013, AND THERE HAVE BEEN NO REPORTS OF SIMILAR INCIDENTS AT THIS LOCATION. THE CORRECT DATE THAT SIEMENS WAS NOTIFIED OF THE EVENT WAS (B)(4) 2013.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2013 OF UNINTENDED TABLE MOVEMENT. REPORTEDLY, THE CT TABLE STARTED TO MOVE WITHOUT COMMAND WHILE A PATIENT WAS ON THE TABLE. THE EMERGENCY STOP BUTTON WAS NOT USED; HOWEVER, THE SYSTEM DETECTED AN ERROR/FAULT AND AUTOMATICALLY WENT INTO STANDBY MODE WHICH STOPPED THE TABLE MOVEMENT. THERE WAS NO INJURY TO THE PATIENT REPORTED. THE INITIAL SCAN WAS UNSUCCESSFUL DUE TO THE TABLE ERROR, BUT IT IS UNKNOWN THE PROCEDURE HAS STARTED OR IF THE PATIENT HAD RADIATION PRIOR TO FAILURE. A SECOND SCAN WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78678 SOMATOM DEFINITION FLASH SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS AG 10431800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other