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	08/09/2025
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 patient injury involving the magnetom altea system.Per the received information, the patient received a 25mm x 25mm burn on the right shoulder during an mri examination using a third-party electrode heart monitoring device.Siemens healthineers has requested additional information regarding the event and the extent of the patient¿s injury.The additional information is pending receipt as of the date of this report.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause could not be determined.It was stated that a patient obtained a 25mmx25mm burn on the right shoulder during an mr examination where a 3rd party electrode heart monitoring device was used.The severity of the patient's burn is still unknown.It is also unknown if any medical intervention was necessary.The used electrode was cardinal health kendall 935 or 855.For investigation siemens requested details about the patient's injury and the following data: dicom images.Questionnaire ((b)(4)).Developer save log.System qa, coil qa and test tools results.Siemens was informed that the customer is unwilling to provide any additional information regarding this complaint.They did not believe that this was an issue for siemens healthineers to deal with.Therefore, no investigation of this complaint was possible.From the complaint description, the patient's burn might have been caused by the electrodes used during the measurement.

• 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; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 22976145
• Report Number: 3002808157-2025-00025
• Device Sequence Number: 21219687
• Product Code: LNH
• UDI-Device Identifier: 04056869230719
• UDI-Public: (01)04056869230719
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 08/25/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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