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	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of a patient injury associated with a magnetom altea system.The reported event indicated that the patient sustained a radiofrequency burn.The patient was evaluated at an urgent care facility, where antibiotics were prescribed and burn ointment was provided.Additional information about the severity of the burn has been requested, but has not been received to this date.Therefore, in-doubt reporting is performed.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.

• 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 ; +1(484)323-4198
• MDR Report Key: 50299373
• Report Number: 3002808157-2026-00020
• Device Sequence Number: 18575013
• Product Code: LNH
• UDI-Device Identifier: 04056869230719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 08/04/2026
• Initial Report FDA Received Date: 08/18/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown