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

Model Number	11574100
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers discovered during field safety corrective action (fsca) xp018/24/s (res# (b)(4).That the securing segment of the fixation for the monitor ceiling suspension was not installed correctly.The issue was resolved on site by the service engineer replacing and correctly installing the securing segment and the fixation screws according to fsca xp018/24/s.No injury occurred due to the reported issue.It is assumed that in a worst-case scenario, if the support arm had been used further without noticing the issue, a serious injury could be sustained from falling equipment.
Additional Manufacturer Narrative
E1: reporter's phone number is (b)(6).A facility contact name was not provided.H3, h6: manufacturer's preliminary analysis: the root cause for issue has not been determined yet.The investigation is ongoing.The root cause will be reported under res# (b)(4).Upon completion of the investigation.Corrective/preventative actions for this system were completed via ui xp018/24/s.A supplemental mdr report will not be submitted for this event.

• Brand Name: LUMINOS LOTUS 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: 21678759
• Report Number: 3004977335-2025-00042
• Device Sequence Number: 7599858
• Product Code: OWB
• UDI-Device Identifier: 04056869269931
• UDI-Public: (01)04056869269931
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 11574100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/24/2025
• 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