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

Model Number	10762472
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.
Event or Problem Description
The corrugated cable and the bracket of the luminos agile max system fell because the screw had come out.The corrugated cable and bracket were reattached with a screw and bolt.No injury was communicated in this case.In worst case scenario, the issue might lead to a minor to serious injury if a person were hit by the falling parts if the issue recurs.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.According to the received information the cable holder was reattached with loctite on the screw by the service engineer.This was also confirmed with provided pictures of this system part.During inspection of those received pictures it was found that the retaining plate of the corrugated hose holder was installed upside down.Immediately after becoming aware of this fact the service organization was advised to correct the orientation of the retaining plate.Afterwards, the correct orientation was also confirmed by further pictures.The corrugated cable holder is now installed as intended.The investigation showed that the cable holder was already installed upside-down at the time of the incident.It was not possible to determine when this part was installed incorrectly.The issue is seen as a workmanship error.An improved description in the service documentation regarding mounting and maintaining the swivel arm of the corrugated hose holder was initiated.No general problem was identified.The complaint has been closed.H11 corrected data: d4: udi number was reported in correct format.H11 corrected data: d4: udi number was reported in correct format.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 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: 17073495
• Report Number: 3004977335-2023-00035
• Device Sequence Number: 12233741
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/24/2024
• 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