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	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: currently no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the investigation is ongoing.A root cause has not yet been determined.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of a potential product malfunction after analysis of the luminos agile max system log files.The provided log files showed a toggling pattern of blocked movement buttons and error 509/017 had occurred several times since (b)(6) 2024.It was unclear if there was any unintended movement during clinical workflow during this time.Information was received on march 11, 2024, stating there was unintended movement starting in the beginning of (b)(6) 2024.The patient table would move only by the user touching the joystick/optigrip without activating a movement button.The unintended movement would have stopped as soon as the user let go of the optigrip.The user can always stop unintended movement by pressing an emergency stop button.It is assumed that this unexpected movement could lead to a serious injury in a worst-case scenario.The issue is therefore now classified as reportable with the new awareness of march 11, 2024.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported toggling pattern of blocked movement buttons found within the log files.Additionally, the issue investigated in a related complaint (b)(4), mfg.Report number 3004977335-2024-00016, the error code 509/017 was observed.The mentioned error code 509/017 indicates that a button is active at the control console during startup.The system recognized the toggling behavior of the button ¿system tilt slow clockwise¿ at the startup and blocked this button for manual use.This can be cleared by a system restart.The investigation of the issue did not identify an exact root cause.The following components were replaced and returned for a detailed root cause analysis: d80 i/o board ir (10494668), optigrip incl.C-arm agile (10657026), control unit_dtf_left (10408907), control unit_dtf_right (10408926), force sensor (force sensor on the dit) (07042315), cable harness image receptor agile (10306307), and (ribbon cables between the d80 and the control units dtf left/right).All replaced parts were analyzed and no problems were identified.Since no malfunction of the components could be identified, the system at customer site was checked again by service technician to resolve a possible grounding issue.Finally, the system and all movements were tested and confirmed to work without problems.No further issues were communicated.Based on all investigation results the most probable cause for this issue is assumed to be a connection problem.During the replacement of the mentioned parts many connections between the components were renewed which resolved a potential connection problem.The complaint is closed with this statement.H11 corrected data: d4: the udi number was incomplete in the initial report submitted to the fda on 18-mar-2024.The complete udi number is (b)(4) was reported in this supplemental report.

• 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: 18920293
• Report Number: 3004977335-2024-00032
• Device Sequence Number: 12662112
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162(21)61228
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/11/2025
• 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