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	Full thickness (Third Degree) Burn (2696)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified regarding a patient injury potentially associated with a magnetom aera body coil.It was stated in the complaint that the body coil was heating up.There were two affected patients.Patient 1 told the customer that he had a burning sensation after an mri examination on (b)(6) 2024.Six months later, the customer was notified by patient 1 regarding this examination stating that a blister has appeared.Reportedly the physician diagnosed it a second-degree burn.Patient 2 underwent an mri examination during (b)(6) 2025.Patient 2 reported that he had a burning sensation during the examination.Pictures of patient 1 were provided to our siemens medical officer.The medical officer could not exclude a grade 2b or 3 by means of the provided images.The patient 1 burn was determined to be a serious injury.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.The root cause of the issue has not been identified.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Siemens healthineers completed a thorough investigation of the issue reported.Root cause analysis: there was an injury associated with this issue.It was stated that one patient reported blisters on the inner thighs about 6 months after their examination which stayed for several weeks.The burn was rated as a second degree burn by a doctor.Our medical officer could not exclude a burn of grade 2b or 3 by the provided pictures.A second patient felt a burning sensation after an examination in april.No details were provided about the exact location of this burning sensation.Our experts analyzed the images generated during the patient¿s examination.Patient 1: the complete examination of the patient¿s pelvis lasted 37.7 min with an active scanning time of 23.4 min.No abnormality was found, which would indicate a system malfunction.The complete measurement was performed in the first level 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 56.3 % of the first level mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 52.1 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).Patient 2: the complete examination of the patient¿s pelvis lasted 50.3 min with an active scanning time of 13.1 min.No abnormality was found, which would indicate a system malfunction.The complete measurement was performed in the first level 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 42.9 % of the first level mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 64.7 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).Qa checks and test tool measurements were performed and showed no signal of a technical malfunction of the system or the used spine rf coil.However, the coil qa checks of the two used body 18 matrix coils (serial numbers: (b)(6)) revealed very low s/n in several receive channels.While these findings may lead to reduced image quality, they do not necessarily pose a safety risk when performing measurements with these coils.No rfswdhistorylist log files were available for the two examinations.Therefore, the sar values were evaluated based on the dicom header information and may be incomplete (e.G., due to aborted measurements).Both examinations were performed in first level-controlled mode.The resulting sar values were below the corresponding limit of 4 w/kg during the whole examination.The most likely root cause for patient 1 is contact between the inner thighs.The mr images of the examination show contact of the two thighs in the affected region, and also a contact point in the knee region.For the second affected patient, insufficient information was provided to clearly determine the root cause for the reported burning sensation.There also might have been a current loop formation leading to increased local heating as the mr images show several contact points between the legs in the thigh and knee region, as well as between the hands and the legs.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 (print no.(b)(4), pages 26-27).Please 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.

• 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: marion mints ; 40 liberty blvd.; malvern, PA 19355 ; 4843231632
• MDR Report Key: 22356787
• Report Number: 3002808157-2025-00013
• Device Sequence Number: 15643226
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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?: Yes
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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 Age: 45 YR
• Patient Sex: Male