MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS PHENO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10849000

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2021

Event Type  malfunction  

Event Description

Hyor 2 c-arm stopped working in the middle of a case.Patient had to be told of mechanical malfunction and possibility of cancelling case while she was on the table.Siemens rep came in and fixed the issue, but room taken down for maintenance all day.Consistent issues with this room that we have reported up to the vp's of siemens with minimal resolution of issues.Here is doctor's account from yesterday: so after reading through the email exchange i feel compelled to communicate how uncomfortable this equipment failure made me this morning.The patient who is a relatively frail lady was in the room on the table and under sedation.She has a single celiac artery stent with in-stent stenosis and occlusion of the sma.I had obtained ultrasound guided access and placed a sheath in the right femoral artery when i attempted fluoro.There was a complete failure of the driver for the flat panel.The c-arm was repositioned multiple times, the system reset and siemens field engineer was called.He attempted to reset the c-arm again and then shut down and restarted the system.Still not working and definitely not safe to proceed with the case.At this point i explained to the patient that we were having mechanical difficulties with the equipment and that we were going to have to cancel the case.She was obviously disappointed but agreed.I was about to pull the sheath and hold pressure when i saw siemens field engineer manually spinning the flat panel detector in a manner that none of us would ever consider.He then reset the system again and felt like he had probably fixed it and it would work.Now, i as the operating surgeon, was put in the position of making a decision to proceed or not proceed with the case based on "it looks like it will work" from the siemens field engineer.We make difficult decisions every day so i made the decision to proceed with the case because it was in the best interest of the patient while full knowing that completing the case would allow siemens to downplay the failure and indeed potentially catastrophic situation that our patient, staff and myself were placed.When i bring a patient in that room to perform a complex procedure, i shouldn't have to wonder if the equipment is going to work or not.I shouldn't have to worry if i'm going to be placing myself in a position to be sued because of a bad outcome due to equipment failure or suboptimal performance.This is where i am right now regarding your equipment and it is extremely sad and frustrating.I don't know what the right solution is for everyone but i know that our entire staff and myself has lost faith in the installed equipment working properly.We need to report this device to the fda - i think we have already completed one several months ago.(dec 2020, trumpf table.Neither vendor, siemens or trumpf, can confirm if the problem is on their side and are collaborating to make sure that it doesn't happen again).Surgeons do not want to use the room (this doctor and other physicians).We need to consider how to move forward considering we received a "lemon".We are also afraid to orient new staff in this room and we cannot tell if it is a competency issue with the employee or machine failures occurring.We are orienting all new staff now in a different room.

• Brand Name: ARTIS PHENO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 11869556
• MDR Text Key: 252166856
• Report Number: 11869556
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2021,04/30/2021

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: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1