MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO; STATIONARY X-RAY SYSTEM

Model Number 10281013

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested for further investigation.A supplemental report will be submitted if additional information becomes available.

Event Description

It was reported to siemens that the user was unable to move the ysio systems even after the unit was rebooted.A siemens service engineer was dispatched to the site.The engineer was able to move the tube stand in transversal direction.The system started to move towards the wall at high speed and stopped at mechanical stop ends.There is no patient involvement in this case.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The described system malfunction was investigated in detail.Logfiles were analyzed and several components of the affected axis were investigated.It was confirmed that the following parts - interface board, scu-software, force sensor, position encoder and motor - did not cause the reported issue.During an on-site examination at the concerned site the motor controller (frequency inverter, type lti cdf30, material number 8673548) was identified as a possible cause for the malfunction.The endurance test at the factory system showed very sporadic malfunction of the motor controller.When the malfunction occurs, a drift in the position value can be identified, which explains the reported issue.Therefore, it was confirmed that the motor controller was indeed the cause of the problem.The investigation also showed that the unexpected movement can only occur with the following preconditions: - the sporadic failure at the motor controller (drift of the current stand position value) and - the dmg button is activated by the operator within the 100ms of this sporadic value drift.However, despite in-depth investigations by the manufacturer, the supplier of the ceiling stand and the supplier of the motor controller, the root cause of the malfunction of the motor controller could not be determined.It was therefore decided to implement a software solution for the affected sw-version vb10 that recognizes the drift of position value and blocks further movement.A system restart will bring the system back to regular operation.The sw solution will be released via an update instruction xp045/19/s.After the replacement of the frequency inverter cdf 30.008 at the concerned site the reported issue has not reoccurred, and no hints of the motor controller malfunction were found in the log files following part replacement.

• Brand Name: YSIO
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8531622
• MDR Text Key: 142532163
• Report Number: 3002808157-2019-63992
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K081722
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10281013
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other