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

Model Number	10432914
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	10/26/2025
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 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 aera system.The patient was provided with both earplug hearing protection during an examination for the full duration of the exam.During the following scan, the patient claimed that they had developed a tinnitus in both ears that was ongoing and not subsiding.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported problem.Siemens was informed that the patient was wearing earplugs for the entirely of the groin examination.The earplugs provided to the patient had a noise attenuation of 28 db.The magnetom aera - system owner manual syngo, mr xa30 states the following: "provide the patient with appropriate hearing protection that lowers noise to at least 99 db(a)." the technical data furthermore states that for this xq gradient hearing protection with an snr = 22 db or more is required.This means that the ear plugs used were appropriate for this system.The needed hearing protection is determined using mgan (maximum gradient acoustic noise).This means that the loudest technical sequence is measured which is always louder than used clinical sequences.The sequences used during the patient's examination (such as tse and haste), are not necessarily among the loudest sequences.The localizer, which only ran briefly, was probably the loudest.There appear to be no issues with this system, such as any hardware changes.Siemens has not been informed about any further issues regarding the noise level of the system.Therefore, we conclude that the system is acoustically normal and the root cause for the patient's tinnitus could not be determined.H11 corrected data: b5: description of event sentence ¿the patient was provided with both earplug hearing protection¿ was corrected to ¿the patient was provided with earplugs for hearing protection¿.
Event or Problem Description
***correction of second sentence*** siemens healthineers was notified of a potential patient injury involving the magnetom aera system.The patient was provided with earplug hearing protection during an examination for the full duration of the exam.During the following scan, the patient claimed that they had developed a tinnitus in both ears that was ongoing and not subsiding.

• Brand Name: MAGNETOM AERA
• 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: 23568225
• Report Number: 3002808157-2025-00039
• Device Sequence Number: 15991407
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 10432914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/17/2026
• 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 Age: 56 YR
• Patient Sex: Male