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

Model Number	10762472
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer facility contact name and email address were not provided for reporting purposes.H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: customer service advisory notification (csan) xp017/24/s began distribution to affected customers on 07/02/2024.Siemens initiated recall res# :(b)(4), which was submitted to the fda on 07/05/2024 for potential problems with the support arm of select system ceiling displays or wall displays.Manufacturers preliminary analysis: the root cause for the issue has not yet been determined.The investigation is ongoing.This system was fixed via resolution update xp018/24/s.Siemens healthineers will not submit a supplemental report because the root cause will be communicated via res# 94948 reports to the fda.
Event or Problem Description
Siemens healthineers was notified of an issue with the luminos agile max system related to siemens recall xp017/24/s, res #:(b)(4).During service for this recall the siemens customer service engineer discovered that the securing segment was inserted the wrong way around and was sticking out.Also, the countersunk screw was not screwed correctly.The cylinder screw looks correctly fixed.The issue was resolved on site by the service engineer replacing and correctly installing the securing segment and the fixation screws according to resolution update xp018/24/s.The customer had not been aware of the issue.The monitor support arm remained attached to the ceiling and no injury occurred in this case.It is assumed that in a worst-case scenario, if the support arm had been used further without noticing the issue, it might have led to a serious injury by large parts falling down and hitting a person.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 3 - or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 3 - or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20923296
• Report Number: 3004977335-2024-00148
• Device Sequence Number: 17466293
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 12/02/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown