BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM DEFINITION AS SYSTEM

    MDR report key: 4013977 · Received May 16, 2014

    Report

    Report Number
    2240869-2013-10287
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    November 3, 2013
    Report Date
    November 14, 2013
    Manufacturer
    SIEMENS AG MEDICAL SOLUTIONS
    Product Code
    JAK
    PMA / PMN Number
    K103127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED EVENT ON (B)(6) 2013. THIS MDR IS BEING MAILED ON (B)(4) 2013. SIEMENS' PRELIMINARY INVESTIGATION REVEALED THAT THE BURNING ORIGINATED FROM THE CBR D11 (ELECTRONIC BOARD) AND THE POWER CABLES INSIDE THE IRSMX2C COMPUTER. THE COMPLETE IRSMC2C - FRU IRSMX2C COMPUTER HAS BEEN REPLACED. HOWEVER, SIEMENS' INVESTIGATION INTO THIS ISSUE IS ON-GOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2013, THAT ON (B)(6) 2013 AT APPROXIMATELY 23:00, THE CT SYSTEM SUDDENLY RESET ON ITS OWN. THEN, THE USER NOTICED A BURNING SMELL THAT WAS COMING FROM THE IRSMX2C AND THE SYSTEM WAS SHUTDOWN IMMEDIATELY. REPORTEDLY, THE BURNING SMELL SPREADS THROUGHOUT THE WHOLE GROUND FLOOR OF THE FACILITY AND EVERY WAS EVACUATED. THERE IS NO REPORT OF INJURY TO A PATIENT OR FACILITY PERSONNEL. THE REPORTED ISSUE OCCURRED IN MALAYSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294635 SOMATOM DEFINITION AS SYSTEM SYSTEM, X-RAY, TEMOGRAPHY, COMPUTED JAK SIEMENS AG MEDICAL SOLUTIONS 08098027 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVICE NO. (B)(4)| SW VERSION VA40A: TWO (2)| IRSMX2C COMPUTER: MAT NO. (1) 1026606 (2) 10162088