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

Model Number	10762472
Medical Device Problem Codes	Component Missing (2306); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of an issue with the luminos agile max system.It was communicated that the mounting screw in the tube attachment of the display ceiling suspension was missing, and the support arm had lowered a bit, but did not fall down completely.No injury occurred due to this 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
Initial corrective actions/preventive actions implemented by the manufacturer: the system was taken out of use as instructed by customer service advisory notification (csan) xp017/24/s which 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.The root cause will be communicated via res# (b)(4).Corrective and or preventative actions via resolution updates xp018/24/s and xp019/24/s.These updates are anticipated to be released in september 2024.This system will be addressed.Siemens will not submit a supplemental report because the issue, and the complaint system status, will be addressed in res# (b)(4) reports to the fda.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20048320
• Report Number: 3004977335-2024-00102
• Device Sequence Number: 8043779
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 08/19/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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