MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS AXIOM ARTIS TC; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problems Computer Operating System Problem (2898); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Brief power outage to entire hospital.Back-up power came on within a few seconds.Patient was having an angiogram procedure when this happened.When the power went out, and the back-up power came on, it took 30 minutes for the siemens computer to reboot.There was no fluoroscopy during this time.Completion of the angiogram was delayed until the computer rebooted.When the main power came back on, the computer rebooted again.The computer then took another thirty minutes to reboot.No injury to patient.Patient did well.However, procedure time was extended due to waiting for the computer to reboot.Siemens was notified of the event by the hospital clinical engineering dept.Siemens is working to develop a fix for this problem (i.E.Computer should continue working without having to reboot).

• Brand Name: SIEMENS AXIOM ARTIS TC
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty blvd.; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 5115628
• MDR Text Key: 27216797
• Report Number: 5115628
• Device Sequence Number: 1
• Product Code: IZI
• 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
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO