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

Model Number	10848600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the artis one system.The user reported that a fire occurred on the system table during patient treatment.The user also reported that the fire was not due to a system failure.It was later reported that the patient passed away.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.At this time, there is no causality between the system error and the patient's death.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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The event logfile analysis on (b)(6) 2021 showed that the system was started at 07:38 and the patient was created at 08:28.Examination was from 8:50 to 11:33 with fl/acq.No bypass and no errors were found.A siemens service engineer was onsite to check the system functionality and the affected parts by the fire.Several fire marks were seen on the table covers, lower body radiation protection and ehc cable.The system was working well from a technical point of view.The affected parts have been replaced for this system.The affected parts (table covers, lower body radiation protection and ehc cable) are designed with nonflammable materials.In this case, only minor fire marks were on the surfaces of the affected parts without further fire spread while system functionality was not affected.The customer did not raise any complaints for the artis one system during this case and confirmed that the system did not contribute/lead to the patient death.It was concluded that no malfunction occurred.The artis one system did not cause/contribute to the fire nor to the patient death, which the causal relationship between serious incident and the system have not been established.

• Brand Name: ARTIS ONE
• Common Device Name: 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
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12793609
• Report Number: 3004754211-2021-03877
• Device Sequence Number: 5718323
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: 04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown