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

Model Number	11410231
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Acoustic Shock (1693)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of an operator injury associated with the magnetom sola system.The reported event indicated that the operator went into the examination room to test how loud the voice instructions were through the headphones.The operator stated that the volume was so loud that it caused acoustic shock and the feeling of a blocked ear.After the system was rebooted, the sound volume returned to normal.Based on additional information received by siemens on august 21, 2026, the operator was treated with steroids.This indicates tinnitus therapy and is considered medical intervention to prevent potential permanent hearing damage or persistent tinnitus.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.The root cause has not yet been identified.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.

• Brand Name: MAGNETOM Sola
• 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: 50454977
• Report Number: 3002808157-2026-00021
• Device Sequence Number: 18552952
• Product Code: LNH
• UDI-Device Identifier: 04056869217864
• UDI-Public: (01)04056869217864
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/26/2026

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: 11410231
• 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: 08/21/2026
• Initial Report FDA Received Date: 08/26/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown