MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591)

Patient Problem Radiation Overdose (1510)

Event Date 09/18/2018

Event Type  malfunction  

Event Description

We were performing a pre-surgical tumor embolization.The physician noted that the image quality was pixelated therefore preventing him from properly visualizing the contrast and embolic agent while embolizing a tumor.There was also a random cross hair effect that typically appears when the table has moved, however, the table or any other piece of equipment did not move.Lastly, there was an error with the system when a dsa roadmap was being performed that the overlay was not able to be done due to the equipment moving.The equipment did not move and the patient had to be exposed to additional radiation and contrast in order for the physician to get the correct working image for the procedure to be successful.

• Brand Name: ARTIS
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 7909637
• MDR Text Key: 121732010
• Report Number: 7909637
• 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: 09/19/2018

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
• 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: 09/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5475 DA