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Patient 1
SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. THE SYSTEM IS EQUIPPED WITH A SQUEEZE BALL AND AN INTERCOM FOR THE PATIENT TO ALERT THE OPERATOR IN THE EVENT OF EXPERIENCING DISCOMFORT. WITH THESE EXISTING SAFETY FEATURES, A DEATH OR SERIOUS INJURY IS UNLIKELY. THERE IS A CLEAR WARNING IN THE MAGNETOM FAMILY OPERATOR MANUAL - MR SYSTEM SYNGO MR E11. IN GENERAL, AN MR EXAMINATION IS CONTRAINDICATED FOR PATIENTS WITH ELECTRONIC OR ELECTRONICALLY CONDUCTIVE IMPLANTS OR METALS, ESPECIALLY THOSE CONTAINING FERROMAGNETIC FOREIGN MATTER. CERTAIN IMPLANTABLE MEDICAL DEVICES HAVE BEEN CLEARED, APPROVED AND/OR LICENSED BY THE COMPETENT GOVERNMENTAL AUTHORITIES AND/OR LABELED BY THE DEVICE MANUFACTURER AS "MR CONDITIONAL". IT IS THE RESPONSIBILITY OF THE DEVICE MANUFACTURER TO DECLARE AN IMPLANTABLE MEDICAL DEVICE AS MR CONDITIONAL IF APPROPRIATE AND TO DEFINE THE CONDITIONS (CONSTRAINTS) FOR SAFE MR SCANNING. THE MR OPERATOR MUST BE AWARE OF ANY SUCH CONDITIONS FOR MR SCANNING. IT IS THE OBLIGATION OF THE MR OPERATOR TO ASSURE THAT THESE CONDITIONS ARE STRICTLY ADHERED TO. TO OBTAIN THESE SPECIFIC CONDITIONS THE MR OPERATOR MAY REFER TO THE LABELING OF THE IMPLANTABLE MEDICAL DEVICE OR CONTACT THE DEVICE MANUFACTURER. SIEMENS MR DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR THE OPERATION OF THE MR SYSTEM WITH ANY IMPLANTABLE MEDICAL DEVICE.