MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM ALTEA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11344915
Medical Device Problem Codes	Accessory Incompatible (1004); Use of Device Problem (1670)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of an incident that involved the magnetom altea system.An oxygen tank was brought inside the mri examination room by hospital personnel.The tank was pulled by the mri machine; a doctor¿s leg was pinned to the machine by an oxygen tank.The mri unit quenched.The doctor required a medical treatment following the incident and needed a surgery.Siemens has requested additional information regarding this event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Assessment of the event 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.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 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.Our experts checked the installation protocol of the affected system at the customer¿s site, which stated that the warning signs have been placed properly.According to our startup instructions these warning signs must be legible and visible even when the door to the examination room is opened.During the investigation, it was observed that the warning signs attached to the door did not meet our specifications as there was a sign only on one side of the door.As a result, a service technician was dispatched to install warning signs according to the specifications.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Assessment of the event 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.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 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.Our experts checked the installation protocol of the affected system at the customer¿s site, which stated that the warning signs have been placed properly.According to our startup instructions these warning signs must be legible and visible even when the door to the examination room is opened.During the investigation, it was observed that the warning signs attached to the door did not meet our specifications as there was a sign only on one side of the door.As a result, a service technician was dispatched to install warning signs according to the specifications.

• Brand Name: MAGNETOM ALTEA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20137272
• Report Number: 3002808157-2024-00015
• Device Sequence Number: 14259525
• Product Code: LNH
• UDI-Device Identifier: 04056869230719
• UDI-Public: (01)04056869230719
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K203443
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 11344915
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 03/31/2025; 03/31/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 03/31/2025; 05/12/2025
• 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