MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM ICONOS R200; IMAGE INTENSIFIED FLUOROSCOPIC X-RAY

Model Number 10093962

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

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

Event Date 02/04/2015

Event Type  malfunction  

Event Description

During an exam with a patient being present on the table of the axiom iconos r200 system, the unit started tilting into a trendelenburg position.Upon reaching the -14 degrees position, the table tilted towards the foot side.According to the provided information, the operator did not initiate any system movement.The patient did not suffer any injuries.The unit was tilted to the 0 degree position and the position was asked to step down from the table.The reported event occurred in the (b)(6).

Manufacturer Narrative

Emergency stop push buttons are available to the operator to stop all device movements should it become necessary.It is yet unclear how the system movement was stopped.A detailed investigation of the system is necessary to determine the root cause of the described issue.Further information was requested.Customer's address: (b)(6).

Manufacturer Narrative

This complaint was investigated with the following result: the investigation of the returned remote control desk and table side control did not show any defects regarding functionality and reliability of the parts.Furthermore, the spare part consumption of both parts has been checked.The consumption shows normal values and has not increased.Moreover, the provided log files have been analyzed and no failure could be determined.It is assumed that the error was caused by a not properly adjusted joystick, which released the tilting movement.The error has not reoccurred since adjustment of the joystick.No systematic issue was determined.This report was submitted april 25, 2016.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE INTENSIFIED FLUOROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; malvern PA 19355 1406
• Manufacturer (Section G): SIEMENS AG; siemenstrasse 1; forcheim 91301 ; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4576712
• MDR Text Key: 5449792
• Report Number: 2240869-2015-05891
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/05/2015

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: 10093962
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other