(b)(4).Siemens has assessed the complained event and concluded that 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, particular safety measures have to be adhered to in order to prevent injuries.Therefore, the magnetom aera operator manual section 2 and the magnetom system owner manual section 1 provides clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.However, 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).
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It was reported to siemens that an adverse event occurred while operating the magnetom aera system.It was stated that when bringing a patient into the room, the customer brought in a magnetic drip stick which was attracted to the magnet.While attempting to remove the drip stick, the technician was pinned between the drip stick and the magnet.The technician suffered a laceration to the right index finger requiring 10 sutures.
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