MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848282

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2017017.(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 q biplane system.During an interventional procedure, the user reported that the image quality had decreased and an error presented on the imaging equipment.No other movements of the table or c-arms occurred and the user started to troubleshoot the equipment.The user was unable to fix the image quality issue and the roadmaps stopped functioning and would not overlay.The user then had to complete a traditional roadmap in order to visualize the pathway which required additional contrast and radiation dose to the patient to create the road map.Siemens has requested additional information in order to conduct an investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be defective hardware.The investigation was performed considering complaint description, cs reports, system log files and system history.The log file analysis shows multiple messages for table transversal movement during roadmap, but no movements were initiated by the user via the control consoles.Because those movements were smaller than 1cm and no actual movements of the table were noticed by the user, this indicates an issue with the table position sensor (potentiometer).In general, during dsa roadmap moving the table longitudinal, transversal, and vertically will cause combined application to reduce exposure (care) position (cross hair) to show in both planes but does not reset roadmap.Table tilt will reset roadmap in b-plane; table rotation will reset a-plane (collimator tracking of table).Any system movement in a single plane will show care position lines in that plane and reset roadmap in that plane opposite plane is unaffected.The potentiometer was replaced by the local service organization.After hardware replacement, no further issues have been reported.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8253009
• MDR Text Key: 133226640
• Report Number: 3004977335-2019-63327
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K123529
• 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: 01/02/2019

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: 10848282
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1