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

Model Number 10094200

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

All system movements can be stopped at any time by pressing the emergency red stop button.A falsely activated control button can potentially be identified by the system during startup.In this case an error message would be displayed, and the system cannot be operated further.It is assumed that the described fault occurred after startup.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.(b)(4).

Event Description

Siemens became aware of an unintended system movement on the axiom luminos drf unit.The table top moved in longitudinal direction toward the head end and pushed monitor cart out of the way without given command.The reported event was a single time occurrence and could not be reproduced.There are no injuries attributed to this incident.

Manufacturer Narrative

The issue was investigated in detail.The reported issue was a single time occurrence, and the behavior could not be reproduced.Therefore, the flight recorder log could not be activated and was not available for investigation.The issue was investigated based on the available log files.The examination of the log files confirmed system movement.The log files indicated that the system longitudinal movement had been initiated by a given hardware signal.This signal is usually triggered by an operator (e.G.Joystick pressed) but can also be a result of a system failure.Therefore, no error messages could be found in the log files as the software could not detect an error.The system has an automatic compensation movement as a special function: when the system longitudinal (column / detector device) reaches the end of the travel range, the tabletop longitudinal moves in the other direction so that the patient remains in the examined area.That means, it is not the direct control of the tabletop longitudinal that causes this axle to move but indirectly the control of the system longitudinal.The investigation indicates that a defective joystick of the system longitudinal in the control console may have caused the issue.It was advised to replace the joystick module as a precaution.The spare part consumption of the potentially concerned part joystick module (material number 10357930) shows values that are below the defined threshold.No general problem is known.All system movements can be stopped by pressing one of the emergency stop buttons, which shut down all system drives.

• Brand Name: AXIOM LUMINOS DRF
• 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: 12671792
• MDR Text Key: 281842775
• Report Number: 3004977335-2021-01465
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062623
• 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: 10/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 10094200
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA 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