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

Model Number	11060815
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Laceration(s) (1946); Tooth Fracture (2428)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: siemens healthineers has initiated an investigation of the reported event.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Event or Problem Description
Siemens healthineers was informed that a ferromagnetic crutch was attracted to the magnet in the mr room, seriously injuring the patient.The patient suffered lacerations, bleeding, and a lost tooth.The patient was taken to an ambulance by paramedics.No further information is available as of the date of this report regarding the patient's current health status.Siemens is awaiting additional information with respect to the patient¿s injuries and provided medical intervention.
Additional Manufacturer Narrative
H3, h6: siemens healthineers has completed the investigation of the reported event.It was initially communicated to siemens healthineers that a ferromagnetic crutch was taken into the magnet room and attracted to the magnet.The crutch hit the patient who sustained a laceration in her mouth and lost a tooth.This injury is considered serious.The customer called an ambulance to have the injuries checked.No further information about any medical treatment is available, other than the first aid performed by the ambulance's paramedics and no further details about the patient's current health status have been provided.We assessed the complained event and 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, particular safety measures must be adhered 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).
Additional Manufacturer Narrative
H11: corrected data: d4: complete udi number added.H11: corrected data: d4: complete udi number added.

• Brand Name: MAGNETOM VIDA
• 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; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18082953
• Report Number: 3002808157-2023-00013
• Device Sequence Number: 20530291
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: (01)04056869039176(21)176254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 11060815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 07/17/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/09/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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