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

Model Number	7391167
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers became aware of a patient incident.The patient alleges that she suffered fractured ribs while having a breast mri procedure.
Additional Manufacturer Narrative
Siemens healthineers interviewed a representative from radnet management to gain more information about the incident.According to the information provided, the patient pressed the squeeze ball as she was entering the mr system stating she felt the bore hugging her chest.Allegedly, the mr technician then manually removed her from the bore without completing the exam and there was no indication in the clinical notes that the patient was trapped or of any associated injury.Allegedly, the mr tech stated the machine "broke down" but the representative was not able to provide any specific details.The mr system has been deinstalled by the customer and is therefore not available for evaluation by siemens healthineers.Siemens healthineers does not have any further information regarding this incident.
Additional Manufacturer Narrative
E1: reporting facility us state was added.H3, h6: siemens healthineers has completed the investigation of the reported event.It was initially communicated that a 72-year-old patient alleged that she was injured on (b)(6) 2021 during a breast mri, causing her to suffer a crushing rib fracture injury.Siemens healthineers was informed about this issue on (b)(6) 2023.The initial information from the customer stated that the issue occurred on a magnetom symphony syngo mr system (serial no.(b)(6)).Siemens healthineers also received the information that the event occurred on a magnetom avanto system (material no.7391167, serial no.(b)(6)).Siemens healthineers interviewed a representative from radnet management to gain more information about the incident.According to the information provided, the patient pressed the squeeze ball as she was entering the mr system stating she felt the bore hugging her chest.Allegedly, the mr technician then manually removed her from the bore without completing the exam and there was no indication in the clinical notes that the patient was trapped or of any associated injury.According to the provided information, the patient had an x-ray while still at the facility on (b)(6) 2024 which was read by the radnet clinical medical director, who is also a radiologist there.Allegedly, there was no evidence of an associated rib fracture.Allegedly, the mr tech stated the machine "broke down" but the representative was not able to provide any specific details.Since siemens healthineers was informed about this issue more than two years after the occurrence, no further investigation was possible.This complaint has been closed.H11 corrected data: d1 ¿ d4, g4: corrected medical device information per additional information provided by the reporting facility.H11 corrected data: d1 ¿ d4, g4: corrected medical device information per additional information provided by the reporting facility.

• Brand Name: MAGNETOM AVANTO
• 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18100977
• Report Number: 3002808157-2023-00014
• Device Sequence Number: 7709849
• Product Code: LNH
• UDI-Device Identifier: 04056869006611
• UDI-Public: (01)04056869006611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 7391167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 07/15/2024
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG