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

Device Problem No Display/Image (1183)

Patient Problem Overdose (1988)

Event Date 09/13/2018

Event Type  malfunction  

Event Description

The patient was in ipp 9 for a coiling procedure.During the case, the md noticed changes in the image quality in the regards to the roadmap shifting even without the breath of the patient.Routes were taken to try and mitigate the issue, but they were unsuccessful in fixing the issue.To avoid wasting time or possibly rupture the aneurysm due to poor imaging, the choice was made to move the whole case to ipp 7.It was also a concern since more scenes, roadmaps, and imaging was needed to clarify the location of the micro catheter, resulting in a high patient dose.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8273166
• MDR Text Key: 133940278
• Report Number: 8273166
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA