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

Model Number	10432914
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(484)323-4198
• MDR Report Key: 50518735
• Report Number: 3002808157-2026-00022
• Device Sequence Number: 13088616
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/31/2026
• 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: Required Intervention
• Patient Sex: Male