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

Model Number 10762472

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens local service rotated the corrugated tubing ceiling coupling 180degrees to provide approximately 4 inches clearance between the tubing and the wall.The engineer temporarily strapped the tubing approximately 1ft.Away from the wall to raise the tube up and clear medical the gas panel.The corrugated tubing mount on lateral bridge was moved as well to mitigate against tubing catching on the end of the lateral bridge.No malfunction of the concerned system was determined; the issue was caused by an improper installation at the affected site.The investigation is on-going a supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

The user of the luminos agile max stated concern regarding the corrugated tube for the 3d overhead tube stand being too close to the wall and rubbing against it.Furthermore, the corrugated tube of the 3d overhead tube hangs low and potentially may collide with a medical gas panel in the wall.No injury or patient involvement was communicated in this case.

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures showed that the ceiling outlet of the corrugated cable hose was located on the system back side wall.The room planning is individually performed for each customer's specific room dimensions.The concerned customer's room plan was also inspected and showed that in this case the system including the ceiling construction had to be positioned next to the wall.The wall to the control room had to be shortened to ensure that the 3d tube can move.As a compromise, the corrugated cable hose passes close to the wall when the 3d tube is moving.The mentioned medical gas panel could be seen in the provided pictures; however, it was not found in the latest revised room plan for this system.Any changes to the exam room after the approval of the room plans cannot be considered.This is stated in the room plan document.To resolve the issues with the corrugated cable hose, the customer was recommended to call siemens local service organization for on-site assistance.The investigation showed that no general problem was identified, and the installation was performed according to the planning guide.Furthermore, there was no indication for a system malfunction.

• Brand Name: AXIOM LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12134938
• MDR Text Key: 263175391
• Report Number: 3004977335-2021-87354
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other