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

Model Number	11291455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/23/2025
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 patient injury involving the magnetom sola system.It was stated that after positioning the patient on the table the operator scheduled acquisitions for the execution of the sequence.On the speaker of scanner, the patient heard that the table would move again for centering of cervical area.As the table starts moving, the patient screams in pain and presses the squeeze ball.The patient's arm was stuck between the bore and the table.Per the complaint report a ct scan confirmed a fracture of the humeral head, which requires surgical intervention.
Additional Manufacturer Narrative
H3, h6: siemens healthineers (siemens) completed the investigation of the reported event.Siemens experts investigated the complaint issue based on the provided information and concluded that the system works as specified.The investigation has shown that there is no indication of a malfunction of the table or the squeeze ball.Siemens communicated to the customer regarding the importance of patients being positioned securely on the table for measurements.It is also stated in chapter 2.2.5 "mechanical hazards" in the operator manual that the patient¿s arms and legs should be secured with straps so that the patient cannot be caught between the tabletop and the magnet cover.This complaint has been closed.No further action is warranted.

• 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 ; 4843234198
• MDR Report Key: 23495897
• Report Number: 3002808157-2025-00036
• Device Sequence Number: 13038020
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: (01)04056869164809
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 11291455
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/23/2026
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 110 KG