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

Model Number	10432914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens evaluated the reported mri system.A siemens customer service engineer was sent to the customer facility on january 17, 2023, to ramp down the mri so that the pistol, magazine, and ammunition could be removed from the mri magnet.The mri's front funnel was detached and had scratch marks but was without major damage.The funnel was repositioned without any problems.It was not possible the identify the reason for the funnel detachment.The cse proceeded with ramp up and verified the tune up/qa of the mri.The mri was within specification.The police were called in for inquiry and removal/collection of weapon/magazine.The customer staff cleaned the mri room.A supplemental report will be submitted if additional information is obtained during the investigation.
Event or Problem Description
It was reported that a serious injury occurred during normal operation and patient positioning in the magnetom aera room.The patient was accompanied by a male companion who had on his person a loaded gun (pistol) and an extra magazine when entering the magnetic resonance imaging (mri) room.The clinic was not informed that the companion was carrying a weapon.The weapon was attracted to the magnetic field of the mri, resulting in the accidental firing of the weapon.The discharged projectile (bullet) lodged in the lower right side of the companion's back.There was no injury to others at the scene, including the patient who was having the mri examination.The injured companion was attended to by the onsite medical team and then transferred to another hospital with the help of the police and fire department.Additional information regarding the extent of the companion's injury, health status, medical intervention, and personal data (age, weight, height, etc.), has been requested by siemens and is pending receipt.
Event or Problem Description
Additional information: siemens was later informed that the injured companion died on (b)(6) 2023, because of this injury.
Additional Manufacturer Narrative
Siemens completed the investigation of the reported event.As previously reported, a companion of the patient entered the magnet room (mri room) with a loaded weapon (pistol) and an extra magazine which were attracted by the magnetic field of the mri.The companion did not inform the clinic that he was carrying a weapon.There was an accidental firing of the weapon, whose projectile lodged in the lower right side of the companion's back.There was no damage to other people who were at the scene, including the patient who was having the mri exam.The injured person was attended by the medical team on site and transferred to another hospital.Later, siemens was informed that the injured companion died on (b)(6) 2023, because of this injury.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, special 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 facility entrance of the controlled access area mri room.

• Brand Name: MAGNETOM AERA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16223620
• Report Number: 3002808157-2023-60407
• Device Sequence Number: 17480458
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K202014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 10432914
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/29/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male