MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ICONOS R200; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 5902775

Device Problem Unintended Movement (3026)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

All system movements can be stopped by the user at any time by pressing the emergency stop button.Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).

Event Description

Unintended system movement was reported for the axiom iconos r200 device.The user stated that the system started tilting without given command from 90 degrees to 0 degrees during a patient exam.In addition to the tilt movement the column started to move towards the foot end.A patient in a wheelchair was present in the exam room during the event, however, the patient was not positioned on the table.There are no injuries attributed to this event.The reported incident occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided error log file did not show any indications for system malfunction, which may have been caused the issue.If a released button or joystick is recognized during initialization, the function is blocked, and an error is stored in the error log.There were no entries pointing to this behavior.The returned joysticks underwent a visual and functional inspection.Physical damage could not be seen.The parts were installed and connected to a regular console on a fully operational iconos r200 test system.Following intensive testing, no malfunction was detected.There was no automatic movement started by itself and when the joystick lever was released, it went always back to middle position and movement was stopped immediately.The spare part consumption of the concerned component (7030765) shows values that are below the defined threshold.A possible cause for this issue could be that the lever of the joysticks kept sticking outside of the middle position when the user released it.This can be caused by dirt between the lever base and the console surface.Since this system generation has no dead man grip function, the movement will continue in such occurrences.Another possible cause would be dirt in the cross-switch potentiometer unit itself.Due to friction the middle position could not be reached, and the movement continued.Whether the dirt fell out when the parts were replaced, while transportation or during the disinfection process can no longer be clarified.The joysticks worked as specified on the test unit and no malfunction could be determined.In case of an unintended movement the system is equipped with emergency stop buttons, which shut down all system drives, and movements are stopped immediately.After the replacement of the joysticks no further tilting issues are known.

• Brand Name: AXIOM ICONOS R200
• 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: 13061198
• MDR Text Key: 285735808
• Report Number: 3004977335-2021-09702
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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: 5902775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other