MAUDE Adverse Event Report: Siemens Healthineers AG MAGNETOM Altea; System, Nuclear Magnetic Resonance Imaging

Model Number	11344915
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of a potential patient injury associated with a magnetom altea mri system.According to the report, the patient complained of hearing issues following an mri examination on (b)(6)2026.The patient wore only headphones during the scan and did not use the combination of headphones and earplugs specified for hearing protection.It was confirmed that the hearing protection warning signage was posted on the examination room door.The patient was evaluated by an ent specialist on (b)(6)2026.Based on additional information received on september 2, 2026, siemens was informed by the customer that the patient was diagnosed with stage 2 temporomandibular joint (tmj) disorder.The customer indicated that no additional information is available from the patient's ent specialist or directly from the patient.The customer also confirmed that the patient did not use the hearing protection prescribed in the system instructions for use and wore only the standard siemens headphones during the examination.As sufficient information is not available to rule out the occurrence of a serious injury, this event is being reported.
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.H6: component code g07002 was utilized for hearing protection.

• 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: 50666638
• Report Number: 3002808157-2026-00024
• Device Sequence Number: 15996190
• Product Code: LNH
• UDI-Device Identifier: 04056869230719
• UDI-Public: (01)04056869230719
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K252838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 09/02/2026
• Initial Report FDA Received Date: 09/08/2026
• 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