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

Model Number 10281013

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available or upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred on the ysio units when the operator pushed the movement button.The system went into full speed and did not stop before it hit the mechanical end stop.There is no injury related to this event.The reported event occured in (b)(6).

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The issue was investigated in detail.The provided log files showed that the position value of the encoder on the tube stand transverse axis was invalid.The motor controller indicated a defective sensor interface (error 30).The dead man grip was found activated during the error occurrence; it is assumed that the operator pressed the handle during the incident.Frequency inverter, engine and rotary encoder were replaced at the concerned site and returned for investigation.No external damage or corrosion could be found.The parts were installed on a test system.The described error could not be reproduced.Additionally, signal transmission errors were simulated as malfunction in the signal chain may have caused the incident.However, every time the system went into safe mode.The described failure case could not be reproduced.A final statement regarding the root cause of the described system behavior cannot be made.The spare part consumptions of the concerned frequency inverter cdf30.008 (material number 08673548), engine xy kpl (material number 07044261) and rotary encoder 12/13 bit ssi (material number 08687720) show values that are below the defined threshold.According to service information the problem did not recur after the mentioned parts were exchanged.

• 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: 8510804
• MDR Text Key: 142525389
• Report Number: 3002808157-2018-45705
• 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: 08/21/2018

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: 10281013
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 01/14/2018
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other