MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM VIDA (DE); SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11060815
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of a potential injury involving the magnetom vida system.According to the complaint report a ferromagnetic iron block was attracted to the magnet.No information has been provided to date if an injury has occurred.Additional information has been requested but not yet received from the customer.
Additional Manufacturer Narrative
E1: a facility contact name and phone number were not provided for reporting.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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.According to the information received there was no injury associated with this issue.It was stated that a ferromagnetic iron block was taken into the magnet room and attracted to the magnet.Due to the strong magnetic field, particular safety measures must be adhered to in order to prevent injuries.Therefore, the corresponding magnetom operator manual and the 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 personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The 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, special warning signs are posted at the entrance of the controlled access area (magnet room).

• Brand Name: MAGNETOM VIDA (DE)
• 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; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 23876618
• Report Number: 3002808157-2025-00044
• Device Sequence Number: 15865573
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11060815
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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: Other
• Patient Sex: Unknown