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

Model Number	10432914
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.The root cause has not been identified.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.
Event or Problem Description
Siemens healthineers was notified of a patient injury involving the magnetom aera system body 18 coil.It was stated that the body 18 coil became hot during the examination and burned the patient between the thighs.Additional information about the severity of the burns and medical treatment provided has been requested by siemens healthineers but has not been received as of the date of this report.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported problem.There was no serious injury associated with this issue.It was stated that a patient felt hot between the legs.After assessing the patient, it was noticed that there were two red circles and blisters between their thighs.No medical treatment was necessary.Siemens experts analyzed the images generated during the patient¿s examination.The system and the used body matrix 18 coil were checked by our service engineer and found to be in specification.Nevertheless, the used body matrix 18 coil was replaced.No anomalies are visible in the mr images of the examination from a technical point of view.There are no indications that a technical malfunction of the used body matrix 18 rf coil led to increased heating in the affected region.In summary no hardware or software problem was found which would explain the patient's burn.Based on the information provided, the most likely root cause for this incident is current loop formation due to direct skin-to-skin contact between the thighs leading to increased local heating.According to the questionnaire, the patient was wearing a hospital gown during the examination, and no distance cushions were used to separate the thighs 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 xa60.The customer was instructed to 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 AERA
• 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: 23568211
• Report Number: 3002808157-2025-00038
• Device Sequence Number: 10155156
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 10432914
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/31/2026
• 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