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

Model Number	11060815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the magnetom vida mr system.It was stated that a patient heating incident occurred in which the patient had a burn to the thighs, although no detailed information about the burn or medical treatment is available.Siemens has requested additional information to conduct an investigation of the reported event; however, the customer has not responded to this date.Therefore, this event is being reported in the abundance of caution.
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 a detailed investigation of the reported event.There was no serious injury associated with this issue.It was stated that a patient noticed a skin redness and heating sensation at the hip.The given information about the injury is not consistent.There were two questionnaires for the same case provided.In one it is written that both sides of the hips were affected.In one it seems that only one side was affected.In the complaint description there is a ¿burn to thighs¿ described, which was not mentioned at all in any of the two questionnaires.This might have been caused by two different radiographers providing the information to two different service engineers.Siemens healthineer experts analyzed the log files generated during the patient¿s examination.The complete examination of the patient¿s hip / pelvis lasted 19.3 min with an active scanning time of 13.5 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 85,4% % 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 23,9 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).Qa checks were performed and showed no signal of a technical malfunction of the system or any of the used rf coils according to the questionnaires.No dicom images were provided.The sar values were below the limit of 2 w/kg during the whole examination.Based on the provided information, a definite root cause could not be provided.However, both a burn at the inner thigh or the hip can be caused by loop formation due to skin-skin contact (e.G.Thigh-thigh or arm-hip).It was stated in both provided questionnaires that no distance cushions were used.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 mr system and coils, syngo mr xa60 (print no.Mr-02601g.621.15.02.02, pages 26-27).The customer was instructed by siemens healthineers to always refer to 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.H11: corrected information: d3.The manufacturer¿s street address was corrected.Email address was added.

• Brand Name: MAGNETOM VIDA
• 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: 23346417
• Report Number: 3002808157-2025-00032
• Device Sequence Number: 15815524
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 11060815
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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 Sex: Unknown