BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM AERA

    MDR report key: 6604058 · Received June 1, 2017

    Report

    Report Number
    3002808157-2017-03018
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    May 20, 2017
    Report Date
    May 25, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH, MR QT
    Product Code
    LNH
    PMA / PMN Number
    K132951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017014. (B)(4). SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE CAUSE OF THIS EVENT WAS THE INTRODUCTION OF FERROMAGNETIC PIECES INTO THE MR EXAMINATION ROOM AND THEREFORE, A USER ERROR. DUE TO THE STRONG MAGNETIC FIELD, SAFETY MEASURES HAVE TO BE ADHERED TO IN ORDER TO PREVENT INJURIES. THEREFORE, THE MAGNETOM AERA SYSTEM OPERATOR MANUAL SECTION 2 AND THE MAGNETOM SYSTEM OWNER MANUAL SECTION 1 PROVIDE CLEAR INSTRUCTIONS AND WARNINGS REGARDING BOTH MAGNETIC FIELD HAZARDS AND TRAINING OF PERSONNEL WITH REGARDS TO MR SAFETY. THE RESPONSIBILITY TO INSTRUCT PERSONNEL AND PATIENTS WHO HAVE ACCESS TO THE MR EXAMINATION ROOM ABOUT MAGNETIC FIELD HAZARDS LIES WITH THE CUSTOMER. THE MANUALS STATE THAT ONLY EQUIPMENT SPECIFIED OR RECOMMENDED FOR USE IN THE CONTROLLED AREA (MR EXAMINATION ROOM) SHALL BE USED. THE INTRODUCTION OF MAGNETIZABLE OBJECTS INTO THE MAGNETIC FIELD IS CONTRARY TO THE STATEMENTS GIVEN IN THE OPERATING INSTRUCTIONS. FURTHERMORE, SPECIAL WARNING SIGNS ARE POSTED AT THE ENTRANCE OF THE CONTROLLED ACCESS AREA (MAGNET ROOM). THIS EVENT OCCURRED IN (B)(6): (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM AERA SYSTEM. THE SYSTEM OPERATOR ENGAGED THE EMERGENCY STOP BUTTON WHEN A METAL TROLLEY WAS BROUGHT INTO THE MAGNET ROOM AND WAS ATTRACTED TO THE MAGNET. THE OPERATORS HAND WAS FRACTURED WHEN THE METAL TROLLEY WAS DRAWN TO THE MAGNET. THERE IS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387286 MAGNETOM AERA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH, MR QT 10432914

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization