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

Model Number	10762472
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No system malfunction has been determined.No general problem has been detected for the installed base which requires an immediate action.According to the currently available information the issue was caused by user inattentiveness.It is in the responsibility of the user to avoid collisions.
Event or Problem Description
During preventative maintenance, the service engineer discovered a crack in a cover of the display ceiling suspension (dcs).It was unclear how the damage had happened.It is assumed that the user tilted the system or collided another object onto the dcs arm by accident.In a worst-case scenario, persons could be seriously injured by falling parts due to a collision of the system or other object with the dcs.No injury was communicated.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.It was stated that during preventive maintenance the service engineer discovered a crack in the cover of the display ceiling suspension (dcs).The investigation results indicated that the damage could only be caused by a collision with the base system or an external object.In general, everything within the movement range or that could cause a collision must be removed before any system movement is initiated.This is also described within the system user manual.The affected cover support arm dcs 12f (material number 8127669) was already replaced at customer site.No system malfunction could be determined.The complaint was closed.H11 corrected data: d3: manufacturer street address was corrected and email added.

• 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: 21228602
• Report Number: 3004977335-2025-00013
• Device Sequence Number: 7559779
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: Other
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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