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

Model Number	10762472
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the luminos agile max system.Based on the provided information, it is understood that the unit would start to tilt when any button on the optigrip or table side control was pressed.With the currently available information, it is assumed that movement stops when the user lets go of the button.No injury was communicated in this case.It is assumed that in worst case a minor to serious injury might be the outcome if the system moves unexpectedly.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
H3, h6: the reported issue stating that the table is tilting when any button is pressed and the axcs network to xcu drops out intermittently was investigated in detail.The analysis showed that different telegrams were sent frequently.The described dropping out of the xcu was identified as a follow up error.When the xcu is overloaded, it shuts down due to the many and long telegrams from the scu.The first results of the investigation excluded all affected control elements as cause of the problem, but it was found that the telegrams origin from the can participant i/o board d80 (10494668).Therefore, the service technician was instructed to replace the d80 board and to check the grounding.However, the problem remains, and the grounding did not have any deviations.Furthermore, the cable harness from the dit (10306307) was replaced.The investigation of this component did not show any damage or malfunction.Shs internal post market surveillance does not indicate a general problem with the spare part.After the service session at customer site, the issue did not reoccur.This indicates that during trouble shooting, measurements and replacement of parts a connection or contact issue causing the described situation was resolved.No general problem with the system is known.The complaint is closed with this statement and without further measures.

• 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: 20125367
• Report Number: 3004977335-2024-00107
• Device Sequence Number: 12633189
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• 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): 07/16/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 07/16/2025
• 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