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

Model Number 5902619

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Siemens received information about unintended movement of the axiom iconos r200 unit.The patient table tilted between two examinations with only the operator being in the exam room.The movement was stopped by pressing the emergency stop.There was no injury associated with this event.There is no patient involvement in this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.According to the provided information from the customer site, the system began tilting movement into minus direction by itself in stand by condition.The system was stopped when 45°position was reached.During the on-site visit siemens local service technician identified a defective joystick at the console cross switch with poti.The joystick was replaced, and the defective one was sent back for further investigation.No physical damage could not be determined on the joystick.The returned part was installed on a fully operational iconos r200 test system.After intensive testing, no malfunction could be detected.There was no automatic movement started by itself and when the joystick lever was released, it always returned to middle position and movement was stopped immediately.It is assumed that the reported issue was caused by the lever of the joystick 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 would continue in such case.However, emergency stop button present on the device will stop all unintended movements.Another possible reason for the described issue is dirt in the cross-switch potentiometer unit itself.Due to friction the middle position could not be reached, and movement continued.Whether some dirt fell out when the part was replaced, while transportation or the disinfection process can no longer be clarified.The spare part consumption of the concerned cross switch with poti shows values that are below the defined threshold.No general problem is 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
• MDR Report Key: 10413348
• MDR Text Key: 203159582
• Report Number: 3004977335-2020-41725
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: 5902619
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other