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

Device Problem Poor Quality Image (1408)

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

Event Date 01/10/2018

Event Type  malfunction  

Event Description

The siemens machine in ipp 9 performed three separate 5sdsa 3d spins.One for the left ica, one for the right ica, and one for the left vert.I arrived into the case after the first 3d spin of the left ica.The image quality of this spin was very sub-par to our standard.I perceived the issue to be a low volume of contrast so to remedy for the next spin, i increased the volume size.The subsequent 3d of the right ica was also of poor image quality like the first.A possible factor was patient moving during the spin, the conscious patient was not perceived to move at all during the final 3d spin of the left vert.The only factor left was either the c-arm or the computer algorithm.

• 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: 8273165
• MDR Text Key: 133946323
• Report Number: 8273165
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA