MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH BIPLANE INTERVASCULAR IMAGING DEVICE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

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

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

Event Date 11/11/2018

Event Type  malfunction  

Event Description

During the procedure, the imaging equipment started losing the image quality.We were looking at the roadmap and it started to get fuzzy.An error presented on the imaging equipment with the cross hair on the screens along with a message "no overlay: system movement after ref image" populated.No other movements of the table or c-arms occurred, so i started to troubleshoot the equipment and changed into two other different programs to establish if the issue is with the program sequence we had selected or if the issue was a system issue.Dr.Stated that he was having a hard time visualizing the stent while this system issue occurred.I was unable to fix the image quality issue with program manipulation.The dsa roadmaps stopped functioning and would not overlay, so dr.Had to do traditional roadmaps to visualize his pathway.This meant we had to give additional contrast and radiation dose to the patient to create the road map.I used a room for call in procedures after this as it was on the weekend and notified my lead.He said he would follow up with imaging.I asked imaging today and he said he informed siemens and they ordered parts and will be fixing it today at 2pm.Manufacturer response for seimens biplane intervascular imaging device, (brand not provided) (per site reporter): rep has been notified and will be coming to evaluate the imaging system.However, this seems to be on ongoing issue with this particular technology.

• Brand Name: BIPLANE INTERVASCULAR IMAGING DEVICE
• 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: 8178636
• MDR Text Key: 130793190
• Report Number: 8178636
• 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: 11/15/2018

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: 11/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA