MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS AGILE MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762472
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: manufacturer's preliminary results and conclusion: the root cause for the issue has not yet been determined.Additional information was requested for the investigation.Initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires an immediate action.The investigation is ongoing.A supplemental report will be submitted to the fda upon completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of an issue with the luminos agile max system.The customer communicated that a patient fell when a piece of the footboard broke off.There were no injuries resulting from the event.It is assumed that, in a worst-case scenario, a serious injury might have resulted from a person falling.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.It was stated that a patient fell when a piece of the footboard broke off.The affected footboard was returned for investigation and was installed on a test system.Throughout the testing process it was possible to attach the footboard exactly as described in the user manual.No malfunction of the locking mechanism could be identified.During repeated attempts, it was not possible to provoke an unintentional release or detachment of the footboard from the table.Even though there was visible damage to the rail on the underside of the footboard, the component remained securely attached during all tests.It could not be determined whether there were any issues with the customer¿s system with the locking mechanism, the visibility of the red and green markings, or if a table mat was used.No evidence regarding a defect in the locking mechanism was submitted.Based on the investigation results there is no indication of any malfunction of the footboard.According to the information from the service engineer, the issue was solved on site with replacement of the footboard (material number 8893385).Shs internal post market surveillance does not indicate a general problem with the spare part.In general, it is recommended to check the footboard again before each use to ensure it is properly attached.The correct handling is described in the operator manual chapter: accessories and auxiliary devices; page 218-220.To further improve the understanding of how to use the footrest, the description in the operator manual has been updated with additional details and illustrations on how to securely attach the footboard.The improved operator manual has been available since 03/2023.For the installed base, an addendum for the improved understanding of the handling of the footboard was released on 6/12/2022 (print no.Xpd0-000g.621.01.02.02) with ui xp051/22/s.The affected customer received the addendum in january 2023.The complaint was closed.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 22245956
• Report Number: 3004977335-2025-00074
• Device Sequence Number: 21342932
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10762472
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/08/2025
• 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
• Patient Sex: Unknown