MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MAGNETOM AVANTO DOT UPGRADE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10684332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a rib injury to a patient undergoing a breast mri exam using a magnetom avanto system.Allegedly, the patient had high body mass limiting the space inside the mri bore.The patient allegedly panicked inside the bore thrashing and complaining of a rib injury.Our investigation couldn¿t confirm the exact nature and extent of the alleged injury and whether it needed any medical attention or intervention.
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted upon the receipt of additional reportable information and/or investigation completion.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction, and no non-conformity was identified.Per the complaint report a patient sustained a rib fracture during their mr examination with a breast coil on (b)(6) 2025.According to the information received, the patient was larger / heavier.It was attempted to move the patient into the bore, but during the first try the patient indicated that it was too tight.The patient was removed from the bore, and some cushions were removed to provide the patient with more space.The patient wanted to try to be examined a second time.This time, the patient fit into the bore, however the space around the patient was limited.This caused the patient to become anxious and claustrophobic and she yelled and thrashed in the bore.When the patient indicated that she heard her rib "pop", she was immediately removed from the bore.The patient was advised by the technicians to have her ribs examined at the emergency room or the urgent care clinic immediately after the examination and again on the afternoon of the same day when the patient called the imaging department stating that her ribs were still very sore.According to information received by the hospital imaging department, the patient's mri breast examination was completed using a wide bore mri at a different hospital on (b)(6) 2025.On (b)(6) 2025, the patient underwent a nuclear bone scan to check for cancer metastasis and to check her ribs for fractures.The customer informed siemens healthineers that they were informed that the patient suffered rib(s) fractures but had no additional details regarding treatment.The name of the patient¿s physician was not provided.Positioning the patient in a way that prevents injuries when moving the table and during the examination lies in the responsibility of the customer.Please always make sure that the minimum distance of 5mm between patient and tunnel covering is always maintained.

• Brand Name: MAGNETOM AVANTO DOT UPGRADE
• 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; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 22892962
• Report Number: 3002808157-2025-00023
• Device Sequence Number: 8851895
• Product Code: LNH
• UDI-Device Identifier: 04056869006635
• UDI-Public: (01)04056869006635
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181613
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 10684332
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 04/13/2026
• 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: Female