The investigation of the event and magnetom skyra system has been completed.The root cause has been identified.It was reported to us that a patient suffered a second degree burn in the buttock area during a pelvic examination.The size of the blister is roughly 7 cm in diameter.The burn was treated at first with debridement and then medication.Additional detailed information was not provided by the hospital.Our experts analyzed the logfiles generated during the patient's examination.The complete examination of the patient's pelvis lasted 95.8 min with an active scanning time of 77.8 min.These are high durations.No abnormality was found which would indicate a system malfunction.The complete measurements were performed in the normal operating mode.The sar values were within the limits defined by the mr safety standard (iec 60601-2-33), i.E., the maximum applied sar was 91% of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 131 wmin/kg which is below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).There is no indication of a malfunction of the mr system.The same system and coils have been in use since the occurrence and no other incidents have been reported.In summary no hardware or software problem was found which would explain the reported blister.It was reported to us that the customer closed this incident with the conclusion that the skin burn was caused by the patient's health status and high sed.The patient has diabetics with proven poor thermoregulation ability.This in combination with a comparable long examination time (77 minutes) and a high energy dose applied (131 wmin/kg) caused the 2nd degree burn.
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