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

Model Number	11344915
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a potential patient injury involving the magnetom altea system.Per the information received from the customer it was stated that the patient was placed feet first into the mri.After the examination, when the patient was removed from the bore, it was noted that the patient had blisters on the inside of both thighs.Medical treatment was provided, however, the extent of the burns and type of treatment provided were not reported to siemens healthineers.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported event.Siemens is unaware of a serious injury associated with this issue.It was stated that the patient noticed blisters on their inner thighs after the examination.Although requested by siemens healthineers, no information about provided medical treatment or an update regarding the extent to the patient¿s burns or patient¿s health status was provided by the customer.Siemens experts analyzed the rfswd history logfile generated during the patient¿s examination (the logfile was extracted from an internal database based on the available patient information: examination date, gender, age; height & weight not provided).The customer refused to provide dicom images for investigation.The complete examination of the patient¿s thigh / femur lasted 59.4 min with an active scanning time of 43.8 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 83.5 % 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 71.5 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 used rf coils were checked by our service engineer and found to be in specification.The sar values were below the limit of 2 w/kg in normal operating mode during the whole examination.This was a relatively long examination with overall high rf exposure.In summary no hardware or software problem was found which would explain the patient's burn.Based on the available information, the most likely root cause for this incident is current loop formation due to skin-to-skin contact between the thighs leading to increased local heating.The patient was wearing hospital gown and boxer shorts, and no distance cushions were placed between 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 xa61.Siemens healthineers 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 ALTEA
• 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: 23450720
• Report Number: 3002808157-2025-00034
• Device Sequence Number: 8345353
• Product Code: LNH
• UDI-Device Identifier: 04056869230719
• UDI-Public: (01)04056869230719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,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: 11344915
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 11/03/2025
• 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
• Patient Age: 56 YR
• Patient Sex: Male