MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM SOLA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11291455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of a potential patient injury involving the magnetom sola.Per the received information from the customer, the patient was burned during an examination.Although requested, no information has been received by siemens healthineers regarding additional event details, extent of the patient¿s burn(s), and any medical treatment that may have been provided.The additional information is pending receipt as of the date of this report.
Additional Manufacturer Narrative
H3, h6: siemens healthineers has initiated an investigation of the reported event.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported event.There was no serious injury associated with this issue.It was stated that a patient sustained redness on the inside of the red arm (small oblong patch).Siemens experts analyzed the rfswd.Log generated during the patient¿s examination, as no dicom images were provided.Please note that the sar values were analyzed based on a rfswd.Log extracted from an internal database.It is not (b)(4) clear if the correct logfile for this incident was used, as the listed patient weight and height noted in the questionnaire do not exactly match the logged values.The complete examination of the patient¿s brain lasted 37.8 min with an active scanning time of 35.5 min.No abnormality was found, which would indicate a system malfunction.The complete measurement was performed in the normal operating mode.The sar values were within the limits defined by the mr safety standard ((b)(6)), i.E.The maximum applied sar was 12.0 % 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 4.4 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard ((b)(6)).The system and the used rf coils were checked by our service engineer and found to be in specification.In summary no hardware or software problem was found which would explain the patient's redness.The root cause is most likely contact between the patient's inner arm and body.It was stated in the provided questionnaire that there was an internal investigation by the customer which conclusion that the root cause of the burn was a "patient position error".The formation of rf current loops based on skin-skin contact might lead to more injuries and should be avoided by using distance cushions.This effect and the preventive measure are described in the magnetom family operator manual ¿ mr system and coils, syngo mr xa61.Siemens instructed the customer to always follow the instructions given in the operator manual regarding correct patient positioning to avoid such incidents in the future.Always position the patient so that the patient¿s arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm).Ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering.To ensure distance, use positioning aids, e.G., blankets made of linen, cotton, or paper, or dry material that is permeable to air.This complaint has been closed.

• Brand Name: MAGNETOM SOLA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 23310064
• Report Number: 3002808157-2025-00028
• Device Sequence Number: 17426916
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: (01)04056869164809
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown