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

Device Problems Image Orientation Incorrect (1305); Poor Quality Image (1408)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/17/2019

Event Type  malfunction  

Event Description

The patient was brought down for a diagnostic angiogram.During the procedure the lateral image would become skewed.When doing a run, the screen would split in half and the bottom portion of the head would be on the top while the top portion of the head would be on the bottom of the screen.After performing the run the screen would flash on the lateral plane.There were two runs, trying different programs to see if that would help, that had significant delays in the lateral imaging.Half way through the case the attending physician opted to only use the ap plane for both ap and lateral images resulting in more radiation exposure and more contrast for the patient.Manufacturer response for siemens artis q biplane, artis q (per site reporter).Paged on call imaging person and came in to repair.

• 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: 8554559
• MDR Text Key: 143239751
• Report Number: 8554559
• 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: 03/11/2019

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: 03/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA