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

Model Number 10502200

Device Problems Output above Specifications (1432); Use of Device Problem (1670); Output Problem (3005); Radiation Overexposure (3017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The instructions for use state that emergency stop button is available to stop all system movement and radiation release; therefore the executed mitigation measure prevented further x-ray exposure.It is estimated that the value of radiation dose applied was minimal.The investigation is on-going and additional information was requested by siemens technical experts.A supplemental report will be submitted if additional information becomes available.

Event Description

It was reported that the luminos agile system released x-ray during a patient procedure without operator giving command.Hospital personnel recognized that the system started x-ray release and the operator stopped the fluoroscopy by pressing the emergency stop button.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.The analysis of the log files showed that the scu (system control unit) rebooted when the problem occurred.However, it could not be determined why the reboot occurred.By rebooting the scu the pending software telegrams are not processed further and the system no longer records when the user releases the radiation trigger.However, the radiation will be interrupted by a hardware circuit.It was found that after a few seconds of fluoroscopy with active radiation (initiated by the user), the radiation was stopped.An image (empty image) still appeared on the monitor and the anode of the tube continued to run.This might have suggested to the user that radiation was still active.In general, the radiation can only be stopped at the triggering location where it was started.Further radiation requirements will be ignored until the radiation at this triggering location is terminated.The only exception is possible acquisition during fluoroscopy.X-ray can always be stopped by emergency stop"-button activation.During the investigation it was found that the user tried several times to stop the "pseudo"-radiation by pressing other radiation release switches.During the reboot of the scu the original activated fluoro switch was reactivated.The scu detected this and blocked it (security function of the software).As a result, the radiation request (no radiation was triggered) from this switch could no longer be terminated.After the scu was ready again, this behavior could be aborted by pressing the "emergency stop" button.A restart of the system was necessary to bring the system back to a functional state.This restart was performed by the user.The investigation of the foot switch did not show any errors or malfunctions.This also corresponds to the result of the log file analysis.The returned rad-controller (d801) was installed on a test system.During these tests the d801 performed reboots sporadically, which indicates a hardware defect on the d801.The exact root cause of this hardware defect could not be determined.The concerned component (d801 corresponds to rad- controller, material number 10140460) has not been manufactured for several years now.This customer system is the only one with this issue that siemens is aware of.This issue could not be found with any other rad- controller (10140460) or the new version of the rad-controller (10140508), neither in tests nor in production line or in the field.The spare part consumption of the affected part could not be determined as it is no longer available and the new version of the rad-controller is currently used.The spare part consumption of the new rad-controller version shows values below the defined threshold.According to the information from siemens service organization the issue has not re-occured since the rad-controller replacement.

• Brand Name: AXIOM LUMINOS AGILE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 7656280
• MDR Text Key: 141601657
• Report Number: 3004977335-2017-07061
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other