BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNETOM ESPREE

    MDR report key: 2200726 · Received August 3, 2011

    Report

    Report Number
    2240869-2011-00030
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    LNH
    PMA / PMN Number
    K041112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SIEMENS SERVICE MAINTENANCE A CONNECTION SCREW WAS NOT PROPERLY TIGHTENED HOWEVER UNINTENTIONAL, AND SIEMENS FACTORY EXPERTS HAVE DETERMINED THIS LED TO THE INCIDENT. THE SITE HAS RECEIVED A NEW SYSTEM REPLACEMENT, MAINTENANCE WORK INSTRUCTION HAS BEEN AMENDED WITH ADDITIONAL CHECKS OF SPECIFIC TEST SEQUENCE AND DOUBLE CHECK OF WORK STEPS, AND TRAINING TO SERVICE PERSONNEL HAS BEEN PROVIDED AS CORRECTIVE ACTION. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN MRI TECHNICIAN RECOGNIZED A BURNING SMELL IN THE EXAMINATION ROOM. THE TECHNICIAN REMOVED THE PT FROM THE MRI SYSTEM AND REMOVED THE PT FROM THE EXAMINATION ROOM. THE EMERGENCY SHUT DOWN SWITCH WAS ACTIVATED TO DISCONNECT THE SYSTEM. SHORTLY AFTER SHUT DOWN, THE FIRE DEPARTMENT ARRIVED HAVING BEEN ALERTED BY THE ALARM FROM THE SMOKE DETECTOR. BEFORE THEY ENTERED THE ROOM THE MAGNET QUENCHED SPONTANEOUSLY. THE FIRE WAS EXTINGUISHED WITH WATER AND CO2. THERE WAS NO HARM TO THE PT, FACILITY PERSONNEL, OR FIRE DEPARTMENT PERSONNEL. THIS INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNETOM ESPREE SYSTEM, NUCLEAR MAG. RESONANCE IMAGING LNH SIEMENS AG 10018165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1