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

Model Number	11060815
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/20/2025
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 potential patient injury involving the magnetom vida system.Per the received information the patient did not feel any burn, but only some heat during the examination; however, the patient noticed burns on the lower back two hours after the examination.Siemens healthineers has requested additional information regarding the event details and the extent of the patient¿s injury.The additional information is pending receipt as of the date of this report.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported event.According to the received information siemens healthineers is unaware of a serious injury associated with this issue.The patient alleged that they discovered skin burns about two hours after an mri examination.During the examination, the patient did not feel a burning, but only some heat.It was stated that the patient did not have any metal objects or jewelry on their body, they did not touch the sides of the bore, nor contact any cables.Information was provided that the patient was feeling well.For investigation siemens healthineers requested a savelog, dicom images, questionnaire, and system and coil qa.Siemens healthineers was informed that both used coils and the system passed the qa checks successfully.Additionally, it was stated that no savelog was available for the time of the patient's examination.The system is not serviced by siemens healthineers and we were informed that our local organization was not successful in retrieving the dicom images of the patient's examination and the questionnaire.Thus, no detailed investigation and no analysis of sar was possible and the root cause for the patient's burn could not be determined.

• 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: 22781820
• Report Number: 3002808157-2025-00022
• Device Sequence Number: 8128005
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 01/29/2026
• 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