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

Model Number	10432914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an adverse event that occurred while operating the magnetom aera system.While being prepared for the head epilepsy scan on the mri machine, prior to contrast being administered, the patient complained about blurred vision, headache, dizziness, and a heating sensation around the head.Additional information was received that a medical team attended to the patient.The patient was taken to the emergency room, however, no information about medical treatment was provided to siemens, and the patient's current health status is unavailable at the moment.Siemens requested additional information to conduct an investigation of the reported issue.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported event of a patient who complained about blurred vision, dizziness, a burning sensation around the head and pain behind her eyes.Siemens healthineers is unaware of a serious injury associated with this issue.Our experts analyzed the images generated during the patient¿s examination.The complete examination of the patient¿s brain lasted 42.8 min with an active scanning time of 31.5 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 (iec 60601-2-33), i.E.The maximum applied sar was 20.3 % (whole body sar) and 83.7 % (head sar) of the normal mode limit respectively.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 8.1 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The system and the rf coils used during the examination were checked by a siemens service engineer and found to be in specification.The used head/neck 20 mr coil 1.5t (material 10496540; serial (b)(6)) was returned for analysis.Only minor deviations were found which can be excluded as the root cause for the described issue.The coil also showed a housing break in the upper part.This was most probably caused by improper handling (e.G.Dropping the coil) but has no impact on patient safety.In summary no hardware or software problem was found which would explain the sensations described by the patient.Some degree of heating during an mri examination is normal and could be an explanation for the given incident.The provided questionnaire further mentioned, that also psychological reasons cannot be disregarded as a possible explanation, especially as the sensation was not only described as heating but also as a ¿general pain¿ and ¿dizziness¿.Hence it is possible that the incident did not have a clear causal correlation to the rf fields generated during mri, which cause tissue heating.No information was found that hints towards strongly increased localized heating.This complaint has been closed.

• Brand Name: MAGNETOM AERA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; henkestrasse 127; 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: 21034648
• Report Number: 3002808157-2024-00017
• Device Sequence Number: 15754928
• 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): 06/12/2025

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: 12/20/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 06/12/2025
• 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