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

Model Number	10762472
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers became aware of a potential product problem involving the luminos agile max system.During service activities the siemens healthineers service engineer noticed that the shaft that connects the monitor support arm (display ceiling stand) to the carriage had slid down several centimeters.The monitor support arm remained attached to the ceiling.There was no injury associated with this issue.It is assumed that in a worst-case scenario, if the support arm use had continued without noticing the issue, it might have led to a serious injury due to large parts falling and hitting a person.
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.The root cause has not been determined yet.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.The analysis of the provided pictures showed that the cylinder screw at the ceiling tube was missing.In addition, the securing segment and the protection sunk screw were installed correctly, but the shaft was not in the correct position.As immediate corrective measure for this system, the display ceiling stand (dcs) was secured by the service technician with a tension belt to prevent it from lowering.Although the service technician fixed the problem with inserting the missing cylinder screw, the whole dcs was replaced and the complaint dcs was returned for a deeper analysis.The component was investigated and was found as specified.The installation report and the pictures taken directly after system startup were analyzed.It was identified that the suspension arm was canted already during installation.The cylinder head screw was missing from the start and was never screwed in.Furthermore, the supplier¿s assembly instructions were checked.No evidence for an incorrect description of mounting or installation could be found.However, it was found that the instructions were not detailed enough and were therefore improved and delivered since may 8, 2024.Based on the investigation results it must be assumed that the incorrect mounting was a workmanship error during system installation.Therefore, the scan (xp017/24/s) was initiated and sent to all potentially affected customers starting on july 2, 2024, asking them to perform a visual check if their dcs is correctly installed and to inform about associated risks (res# (b)(4)).In addition, the field update xp018/24/s was released on october 8, 2024, for each potentially affected system where the securing segment and the two affected screws are replaced.This is to ensure that the whole installed base will have the same correct status.In case of dcs damage the field update xp019/24/s, also released on october 8, 2024, is intended to repair the dcs.The conclusive root cause will be communicated via res# (b)(4) since it is still under investigation.This complaint has been closed.

• 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: 18993737
• Report Number: 3004977335-2024-00036
• Device Sequence Number: 14185948
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162(21)64127
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: Other
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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