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

Model Number 10093962

Device Problems Unintended System Motion (1430); Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported event is on-going.A supplemental report will be submitted if additional information becomes available.(b)(6).

Event Description

Siemens became aware of unintended system movement of the axiom iconos r200.During a procedure the operator noticed that the table slowly tilted without any control key or lever being touched on the control desk.The movement was performed towards the head position from 0° (table horizontal) to minus degrees.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The reported issue was investigated with the following result.The described behavior was caused by a de-calibrated joystick.This behavior could be reproduced as shown in the provided videos.Following the re-adjustment of the joystick by the service technician, the issue at the concerned site was resolved.The joystick was later exchanged following the successful re-calibration and requested for further investigation, however, it was not provided despite several requests.Therefore, a detailed analysis of the joystick was not possible.The spare part consumption of the concerned part (cross switch with poti, material number 7030765) shows values below the defined threshold.In the maintenance instructions the adjustment of the joystick is part of the required actions (see xpd3-340.831.20.07.02, chapter 5.2.12.2 options, checking the unit control console for function and damage).

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8514017
• MDR Text Key: 145915288
• Report Number: 3004977335-2019-77543
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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: 04/10/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other