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

Model Number ARTIS Q BIPLANE

Device Problem No Device Output (1435)

Patient Problems Therapeutic Effects, Unexpected (2099); Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2019

Event Type  malfunction  

Event Description

Lateral tube of biplane room suddenly stopped working during a stroke case.At this time, clot began forming in the vessel.During this time, we were unable to document multiple runs documenting the case.Unknown cause of failure.Reboot attempted and was successful.Workstation attached is currently not able to save store monitor images for filming.Clinical imaging notified.Siemens notified.Manufacturer response for biplane device, siemens artis q biplane (per site reporter).We have had ongoing issues with this siemens device and they have not been able to resolve our problems.However, these are critical issues that we really need some feedback and resolution.

• 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: 8955878
• MDR Text Key: 156299347
• Report Number: 8955878
• 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: 06/18/2019

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
• Device Model Number: ARTIS Q BIPLANE
• 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: 06/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA