MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10280959

Device Problem Insufficient Information (3190)

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

Event Date 03/21/2018

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 artis zeego system.During an interventional procedure the store monitor was not functional.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.The root cause could not be determined as the replaced ias pc was not returned for investigation.The investigation of the log files showed that the ias pc could not connect to the ivs pc through the high speed link network (netlink disconnect) resulting in a high speed link error displayed on the control monitor and the examination room monitor.According to the log files the user continued to use the system performing fluoroscopic imaging.But since the network connection between the ias pc and the ivs pc failed the "store fluoro" option was not available on the graphical user interface in the control room.Therefore the user could not store the scene.The replaced ias pc was not returned for investigation.The most probable cause for a high speed link error is a failure of the network port on ias pc.This was confirmed during a simulation of the reported issue.On the affected system the ias pc was replaced.No systematic issue in the field was identified.No corrective action in the installed base is planned based on the present event.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 7402706
• MDR Text Key: 104567061
• Report Number: 3004977335-2018-22658
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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: 10280959
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1