MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO X WORKPLACE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 10281299

Device Problem Use of Device Problem (1670)

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

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the syngo x workplace system.During an interventional procedure, the user reported that while attempting to setup for 3d, the system would not boot correctly.The patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The analyses of the provided log files did not show any hints about system related issues or abnormalities.The service engineer found that there was no image visible on the right side monitor in the control room.After turning off the power to monitor and restarting, the image was visible.The service engineer performed a shutdown of the system and the system rebooted as expected.No other system related issues were identified.This was a single event in the power-on procedure of one of the control room monitors.There was no functional limitation for the in-room control/viewing in the examination room.2d imaging of the artis system was available at all times.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized and this event is considered as a single occurrence event.

• Brand Name: SYNGO X WORKPLACE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8115242
• MDR Text Key: 141592860
• Report Number: 3004977335-2018-41383
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K143319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10281299
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1