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

Model Number	10762472
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: 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# 94948, which was submitted to the fda on 07/05/2024 for missing or loose mounting screws in the support arm of select system ceiling displays or wall displays.Manufacturers preliminary analysis: manufacturer's preliminary results and conclusion: the root cause for the issue has not yet been determined.The investigation is ongoing.The root cause will be communicated via res# 94948.Corrective and or preventative actions via resolution updates xp018/24/s and xp019/24/s will be implemented.These updates are anticipated to be released in september 2024.No supplemental report for this complaint will be submitted to the fda.
Event or Problem Description
Siemens healthineers was notified of an issue with the luminos agile max system.The siemens customer service engineer was on-site and identified that the allen (mounting) screw in the tube attachment of display ceiling suspension was missing.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 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., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 19804066
• Report Number: 3004977335-2024-00080
• Device Sequence Number: 7387038
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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: Other
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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