MAUDE Adverse Event Report: SIEMENS SIEMENS ARTIS Q BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 30466

Device Problem Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

During an a-fib ablation procedure in the electrophysiology lab, the siemens artis q needed to be rebooted due to the visualization of fluoroscopy equipment displaying large dark lines across the monitor/field obstructing the cardiac mapping.

• Brand Name: SIEMENS ARTIS Q BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS; malvern PA 19355
• MDR Report Key: 16597829
• MDR Text Key: 311960926
• Report Number: MW5115922
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30466
• Device Catalogue Number: 10763569
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White