BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM DEFINITION

    MDR report key: 3900185 · Received April 30, 2014

    Report

    Report Number
    2240869-2014-02911
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAK
    PMA / PMN Number
    K122471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS RECEIVE NOTIFICATION OF THE REPORTED INCIDENT ON (B)(4) 2014. THIS MDR IS BEING MAILED ON (B)(4) 2014. SIEMENS' CUSTOMER SERVICE ENGINEER (CSE) INVESTIGATED THE ISSUE AND DETERMINED THAT THE UNLOAD BUTTON ON THE LEFT CONTROL PANEL WAS STICKING AT THE TIME OF THE INCIDENT. THE CSE REPLACED THE LEFT CONTROL PANEL WITH A NEW ONE AND THERE HAS BEEN NO REPORT OF THE ISSUE SINCE THEN. CONSIDERING THIS, NO CORRECTIVE ACTION IS INITIATED. CUSTOMER ADDRESS: AFFILIATED HOSPITAL OF (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED ON (B)(4) 2014 THAT AT THE START OF A PATIENT SCAN THE TABLE (PHS) SUDDENLY MOVED OUT AUTOMATICALLY WITHOUT COMMAND. REPORTEDLY, THE VENOUS TUBE THAT WAS CONNECTED TO THE PATIENT'S TRANSFUSION NEEDLE WAS PULLED, HOWEVER, THE NEEDLE WAS NOT PULLED FROM THE PATIENT AS THE TUBING WAS LONG ENOUGH TO ACCOMMODATE THE TABLE MOVEMENT. THERE IS NO REPORT OF INJURY TO THE PATIENT. THIS REPORTED ISSUE OCCURRED IN CHINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259924 SOMATOM DEFINITION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS MEDICAL SOLUTIONS USA, INC. 07740769 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEFT CONTROL PANEL