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

Model Number	10018223
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of a patient incident involving the magnetom symphony a tim system.A patient in critical condition was brought into the mri examination room with four attached perfusor pumps with stabilizing medication.The perfusors were attracted by the magnet and ended up on the side of the front cover.The impact damaged the perfusors, so the necessary medication was not administered.It is unknown, as of the date of this report, if this event may have contributed to the patient's death shortly after the incident.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported event.The described incident was not related to a malfunction of the device.Siemens healthineers concluded that the cause of this event was the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.Due to the strong magnetic field, special safety measures must be adhered to in order to prevent injuries.The corresponding magnetom operator manual and magnetom system owner manual provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.However, the responsibility to instruct staff and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The system owner manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of ferromagnetic objects into the magnetic field is contrary to the statements given in the operating instructions.Furthermore, during the installation of the system, special warning signs were posted at the entrance of the controlled access area (magnet room).

• Brand Name: MAGNETOM SYMPHONY A TIM
• 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: 22613750
• Report Number: 3002808157-2025-00018
• Device Sequence Number: 9564924
• Product Code: LNH
• UDI-Device Identifier: 04056869020471
• UDI-Public: (01)04056869020471
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 10018223
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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 Sex: Unknown