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

Model Number 11060815

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Tooth Fracture (2428)

Event Date 10/25/2023

Event Type  Injury  

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 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.

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).

• Brand Name: MAGNETOM VIDA
• Type of Device: 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 ; 8483234198
• MDR Report Key: 18082953
• MDR Text Key: 327480319
• Report Number: 3002808157-2023-00013
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: 04056869039176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other