MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM SYMPHONY, A TIM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10018223
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Concussion (2192); Anxiety (2328); Peripheral Nervous Injury (4414); Muscle/Tendon Damage (4532)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of an adverse patient event by medwatch report# mw5180015 provided by the fda on december 11, 2025.The medwatch report was completed by the patient.According to information provided by the patient during a phone interview, on (b)(6) 2022, the patient weighing 265 pounds with a history of claustrophobia underwent an mri procedure for abdominal imaging without sedation using the magnetom symphony, a tim system.This system has a 60" bore.During the examination, the patient allegedly sustained a concussion, a rotator cuff tear, nerve damage, ruptured disc(s) of unknown location, and sprains to the ankle and thumb.The patient reports experiencing ongoing chronic pain and emotional trauma and remains under medical treatment.At this time, there is no information to suggest that the subject device malfunctioned or failed to operate as intended.
Additional Manufacturer Narrative
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 healthineers contacted both the patient and the customer site to obtain additional information regarding this event.Both refused to provide the provide the dicom images of the patient¿s examination.Therefore, siemens healthineers reviewed all service calls for the magnetom symphony, a tim system mr system located at baycare outpatient imaging for the months of september ¿ december 2022.There were no service calls or service activities within this time period related to events as described in mw5180015.According to mw5180015, the patient pressed the squeeze ball when first being moved into the magnet bore.If a patient presses the squeeze ball, the operator will be alerted acoustically and visually.Acoustically: - continuous tone over the intercom - audio signal through the patient¿s headphones and through the loudspeaker in the examination room (only as long as the patient squeezes the bulb) visually: - led of the speak button and listen button on the intercom light up system log files were not available any longer due to the event occurring in 2022.Therefore, our experts were not able to determine whether the patient alerts functioned as intended.However, according to the magnetom family operator manual ¿ mr system syngo mr b19 (print no.Mr-01501g.621.01.02.02, page 45) the functionality of the squeeze ball must be checked daily.We have not been alerted by the facility about any alert alarm failures with the system.As no dicom images of the patient¿s examination were provided, an evaluation of the images with regards to patient positioning was unfortunately not possible.The magnetom family operator manual ¿ mr system syngo mr b19 (print no.Mr-01501g.621.01.02.02) provides different warning messages regarding mechanical hazards during vertical and horizontal movement of the patient table and patient positioning: - ensure that there are no obstacles (e.G.Extending or overhanging body parts, hair, clothing, straps) between table and the magnet, or that the additional equipment (e.G.Iv tube, respirator or ecg) does not get caught and remains in and on the patient when moving the tabletop.- secure the patient¿s arms and legs with straps so that the patient is not caught between the tabletop and the magnet cover.Remain in the mr examination room with helpless patients (e.G.Children and patients who are either seriously ill, paralyzed, unconscious, sedated, handicapped or medicated), even if the patients are secured during the examination.- keep the patient under visual or acoustic control.- in case of hazardous conditions, press the table stop button - explain the significance of protocol-controlled table movements to the patient.Due to the lack of necessary objective data, a definitive root cause could not be determined.However, based on the available information and the review of the service notifications, no evidence of a device malfunction was identified.

• Brand Name: MAGNETOM SYMPHONY, A TIM
• 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; allee am röthelheimpark 2; erlangen 91052 ; GM 91052
• Manufacturer Contact: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 23876585
• Report Number: 3002808157-2025-00043
• Device Sequence Number: 20026515
• Product Code: LNH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10018223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 265 LB
• Patient Race: Black Or African American