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

Model Number	10432914
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.The root cause has not been identified.A supplemental report will be submitted upon the 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.Per the received information, the patient received a burn on his cheek from the head coil used during the examination.Siemens healthineers has requested additional information regarding the event and the extent of the patient¿s injury.The additional information is pending receipt as of the date of this report.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction, and no non-conformity was identified.There was no injury associated with this issue.It was stated that a patient noted a warming sensation on their cheek at the time of the examination.The staff assessed the patient for possible burns but there were no signs of skin redness or any other signs of burns.No dicom images were provided for analysis and no rfswd.Log files could be retrieved for this examination.Therefore, no analysis of sar values was possible.The system was checked by our service engineer and found to be within specification.The used head/neck 20 mr coil 1.5t (material # 10496540; serial # (b)(6)) was returned for analysis.No deviations were found, all measured values were within specification, and no safety relevant deviations could be detected.In summary no hardware or software problem was found which would explain the patient's heating sensation.However, it is well known that patients react differently to rf exposure, i.E., some persons may feel heating sensations where others may not.Therefore, there is reason to believe that the complained issue may be related to the individual sensitivity of the patient.

• 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; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 22976117
• Report Number: 3002808157-2025-00024
• Device Sequence Number: 21174775
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 08/22/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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