MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 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 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting an investigation of the reported event.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

During service activities siemens local service engineer found that parts of the under-table tube carriage intended to activate a switch for position detection were loose.In the reported case the switch could no longer be activated.According to internal expert opinion, the issue cannot lead to a collision or injury, but it will cause interruption of radiation exposure as the system is unable to receive confirmation that it is in operating position due to the switch not being active.In the worst case, a delay in diagnosis as well as repeated application of contrast agent is possible.One of the provided pictures showed that the outer insulation of a high voltage cable was damaged as well.The service engineer confirmed that during testing the system displayed an error message to check high voltage.He also found several smaller nicks and a large gash in the cable.Beneath the gash the wiring could be seen.The unit was immediately shut down until further repairs to prevent any potential injuries.No injury or patient involvement was communicated in this case.

Manufacturer Narrative

Siemens is conducting an investigation of the reported event.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

During service activities siemens local service engineer found that parts of the under-table tube carriage intended to activate a switch for position detection were loose.In the reported case the switch could no longer be activated.According to internal expert opinion, the issue cannot lead to a collision or injury, but it will cause interruption of radiation exposure as the system is unable to receive confirmation that it is in operating position due to the switch not being active.In the worst case, a delay in diagnosis as well as repeated application of contrast agent is possible.One of the provided pictures showed that the outer insulation of a high voltage cable was damaged as well.The service engineer confirmed that during testing the system displayed an error message to check high voltage.He also found several smaller nicks and a large gash in the cable.Beneath the gash the wiring could be seen.The unit was immediately shut down until further repairs to prevent any potential injuries.No injury or patient involvement was communicated in this case.

Manufacturer Narrative

The issue was investigated in detail.A large gash and furthermore a loose metal part was found during an inspection.Therefore, the system was taken out of use by service immediately after recognizing the damage.The analysis showed that both issues must be evaluated separately: the broken metal part is a part of a latch from the tube carriage, which holds the retractable tube of the basic unit in place.If this part breaks, the tube cannot fall out of the slide since another bolt is present to prevent this.In september of the 2014 the affected part of the system was improved.This reported occurrence is the only known case since the improvement was introduced.The affected part was requested for further investigation but could not be provided since it was already scrapped.Therefore, it is no longer possible to determine whether the part was already an improved one.The provided images of the damaged high voltage cable were analyzed.Internal shielding and defective insulation could be found, and the cut reached to the core of the cable.However, the position of the cable is not easy for the user to access to touch the high voltage.Since the cables were scrapped as well, no further investigation was not possible.Attempts to recreate the process that led to the damaged cables were made on test systems in the lab.It was found that if the cables have not been fastened properly with cable binders, they may get pinched between the tube support and the basic unit.It could no longer be determined at which point in time the cable was fastened incorrectly.It is still possible to move the dit/tube support in longitudinal direction.In doing so, shear forces would act on the cables which could cause the described damage.No system malfunction could be identified.The affected parts were replaced by local service, and the system was returned to use.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 13266506
• MDR Text Key: 285931961
• Report Number: 3004977335-2022-11957
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other