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

Model Number	10276755
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information is provided.
Event or Problem Description
Siemens was informed about an adverse event that occurred while operating the magnetom verio system.During a prostate scan with a flex coil, the patient received a possible skin burn.Additional information about the event was requested by the user and the customer's service provider.However, this information has not been received to this date.Siemens is conduction an investigation of the reported event.
Additional Manufacturer Narrative
D3: manufacturer¿s email address was added.H3, h6: siemens healthineers (siemens) attempted to investigate the reported problem.The customer does not use siemens healthineers service for this system.Siemens healthineers made several attempts to contact both the customer and their ge service provider to obtain the necessary information.Neither the customer nor their service provider answered siemens requests.As the customer does not allow site visits without prior permission, no data could be retrieved and no investigation was possible.Therefore, the root cause for the potential patient burn could not be determined.This complaint has been closed.H11 corrected data: d3, g1: manufacturer¿s street address was corrected to allee am röthelheimpark 2.

• Brand Name: MAGNETOM VERIO
• 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: 23742131
• Report Number: 3002808157-2025-00042
• Device Sequence Number: 12876731
• Product Code: LNH
• UDI-Device Identifier: 04056869006673
• UDI-Public: (01)04056869006673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 10276755
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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