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

Model Number	11291455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers (siemens) was notified of a patient health event associated with an examination performed using a magnetom sola mri system.According to the customer, the patient had a known history of allergies to latex and perfumes/fragrances.Shortly after the examination, the patient developed tingling and itching of the hands, which progressed to generalized pruritus and worsening symptoms.Subsequently, the patient experienced widespread raised skin lesions and significant respiratory difficulty.The patient sought treatment at an urgent care facility, where she received adrenaline, hydrocortisone (100 mg), and chlorphenamine.The patient reported that she was formally diagnosed with anaphylaxis following the event and was subsequently prescribed an epipen.The symptoms resolved within approximately one hour, and the patient made a full recovery.Due to the severity of the reaction and the requirement for emergency medical intervention, this event is considered reportable.
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.

• Brand Name: MAGNETOM Sola
• Common Device Name: System, Nuclear Magnetic Resonance Imaging
• Manufacturer (Section D): Siemens Healthineers GmbH; 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: 50866824
• Report Number: 3002808157-2026-00025
• Device Sequence Number: 13434551
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: (01)04056869164809
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 09/23/2026

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: 09/09/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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