It was reported that a 13-year-old patient felt a burning sensation and pain after several hours following an mr examination of the patient's elbow on (b)(6) 2022.Siemens healthineers conducted a detailed investigation of the incident and based on the then available information and concluded that no there was no indication of serious injury or system malfunction.Therefore, this issue was initially classified as not safety relevant.Subsequently, on (b)(6) 2022, additional information was provided to siemens healthineers about the patient's injury.Siemens healthineers was informed that patient's lateral right thigh and a rectangular shaped area under the right shoulder blade, approximately 2-3 inches from the mid-back, were blistered because of the mri imaging.The patient was treated at home.Professional medical treatment was not sought.
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A facility contact name was not provided to siemens.Siemens conducted a detailed investigation of the reported event.The system was checked by a service engineer who conducted a detailed examination of the system's records and found that the system performed according to its specifications and defined limits.There was no indication of system malfunction.Additionally, the system's operator manual includes necessary warnings to prevent burns, including direction to a user to avoid patient's direct skin contact with the system and to avoid patient blankets and covers containing metallic threads, requiring use of covers only made of paper, cotton or linen while imaging.Print no.(b)(6).Internal id# (b)(4).
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