MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10848283

Device Problems Break (1069); Device Stops Intermittently (1599); Improper Device Output (2953)

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

Event Date 10/09/2017

Event Type  malfunction  

Event Description

History the system completed installation in 2016.One month after installation, imaging technology management (itm) was made aware of an inaccuracy in the dose reporting readout of the system.Itm clinical systems engineer placed a service call to siemens.A siemens customer service engineer (cse) came in to troubleshoot.Siemens cse and itm clinical systems engineer determined the problem to be a broken diamentor cable.The diamentor is a device used to measure radiation output at the x-ray tube.Itm clinical systems engineer worked with the operating room staff to schedule the room down for the cable replacement.Siemens cse and itm engineers replaced the diamentor cable without factory assistance on two months after installation.Total downtime required was 16.5 hours.Upon completion of the cable replacement, the system was fully calibrated and tested and was found to be working within factory specifications.Current situation last month, itm clinical systems engineer was notified by ir techs that the dose report for their current patient was blank.Upon investigation, clinical systems engineer determined the issue had been occurring for some time.Many existing studies had dose reports showing 0.00 mgy dose.However, some dose reports showed values for the dose, so the problem was deemed intermittent.Itm placed a service call to siemens that day.Itm clinical systems engineer notified itm physics coordinator of the issue verbally.Due to availability of the operating room, siemens cse and itm clinical systems engineer diagnosed the problem as likely a bad diamentor cable, two weeks later.It was also determined that the entire c-arm cable harness should be replaced because the diamentor cable has been replaced once previously.Siemens cse escalated the problem to siemens uptime technical support in cary, nc.The issue was brought up at the fluoro radiation safety committee meeting soon after.At the meeting it was determined the problem needed further consideration by or leadership and risk management, and it should be repaired as soon as possible.Leadership subsequently determined that the imaging system should not be used until the cable is replaced.Siemens cse escalated the issue to the siemens factory the next day.The siemens factory has officially stated that the diamentor cable replacement needs to take place with factory assistance.The siemens factory is in the process now of arranging to send an engineer to oversee the field replacement of the entire c-am cable harness.[date redacted in 2016] siemens ordered a new chamber and cable for the diamentor.One of them is bad.[one day later] used the new parts to troubleshoot the problem to a bad cable for the diamentor.C-arm cable harness needs to be replaced.Uptime is escalating this issue for assistance.[one month later] replaced diamentor cable.Tested.Factory assistance was not required.[last month] looked at system, some runs have a dose, some don't some reports are completely all zeros and some have mixed numbers and zeros.Similar to an issue we had right after install where the diamentor cable was replaced.Called siemens for service.[three weeks ago] troubleshooting for bad diamentor cable.Moved cable harness around in multiple directions.Could not get any reading from the diamentor.Siemens to follow up with uptime and order the c-arm cable harness since the diamentor cable has already been replaced in the past.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; robert phillips; 40 liberty boulevard mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6964920
• MDR Text Key: 89857398
• Report Number: 6964920
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017,10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848283
• Other Device ID Number: SOFTWARE VERSION VD11C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1