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

Model Number	10848600
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation.Yet been determined.A supplement report will be filed if additional information becomes available.H6 - component is unknown.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis one system.During an interventional procedure, no system movements were avaible to the user.The patient had to be relocated to a different medical facility to complete the procedure on an alternate unit.
Additional Manufacturer Narrative
The detailed investigation has been completed and was based on log file analysis, on-site investigation, and returned parts analysis by technical expert teams.According to the initially provided information, system movement was not possible during interventional procedure.Patient was relocated to the nearest hospital (about 3 kilometers away) for the procedure.The investigation showed that easi v77(proxy se) safety signal was activated due to incorrect logic processing on x24 proxy of easi board, resulting in et200s and ncu detected the activation of safety signal (sf) and then blocked normal system movement function.Further analysis found a broken optocoupler on easi board.Furthermore, during expert team on-site investigation, black substance was found on most ground wire terminals and exposed copper wires of the device, which seemed to be caused by accelerated aging oxidative corrosion and the pungent smell was detected in the equipment room and exam room, and the sewage pipe was found nearby.Two unsealed sewage discharge wells were set up about 20 meters away from the equipment room for discharging all the sewage from the whole hospital, with a very high concentration of sewage discharge gas in the underground space.The system movement issue was directly caused by the defective easi board.In addition, since the system has been placed and operated in the irritating gas environment generated by the sewage discharge for up to 8 months, its electronic components and some power supply cables are vulnerably affected by potential corrosive gases directly or indirectly, which can easily lead to/contribute to system malfunction.System was back to normal after easi board replacement.The customer was advised to improve the environment.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.No systematic issue was identified.No further action is necessary.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: ARTIS ONE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center gaoxin c av; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center gaoxin c av; or rittigfeld 1; shenzhen 51805 7; CH 518057
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18065132
• Report Number: 3004754211-2023-00005
• Device Sequence Number: 7585221
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: (01)04056869009964(21)82928
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 07/18/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/28/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown