MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848600

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis one system.During a procedure for embolization of hepatic pseudo aneurysm via stent, the user reported that the system could not perform x-ray.The patient was safely removed from the system and transferred to an alternate non-siemens system, however, the procedure could not be completed due to an unknown failure.At this time, the patient continues to be hospitalized in stable condition and is awaiting continuation of treatment.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.During the investigation, it was determined that the small focus of the x-ray tube failed.The customer continued to use the system for some time until the large focus also failed and x-ray was no longer possible.The system was evaluated by a siemens customer service engineer.The engineer replaced the x-ray tube and the d470 pcb board in the generator and the system was returned to normal operation.During further investigation of the replaced x-ray tube and d470 pcb board, it was found that the failure of the small focus of the x-ray tube was caused by emitter normal wear-out.The large focus of tube was functional.A defect of the igbts on the d470 pcb board was found.After a defect of the small focus, the system switched to large focus.The long term fluoro on the d470 led to an overheating of the igbts on the d470, which ultimately led to large focus failure.The local service organization replaced the x-ray tube and the d470 pcb board and the error did not reoccur.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS ONE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• MDR Report Key: 8514161
• MDR Text Key: 142501352
• Report Number: 3004754211-2019-77168
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K133580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1