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

Model Number	10848600
Medical Device Problem Codes	Radiation Output Failure (4027); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).H6: siemens healthineers has initiated a detailed investigation of the complaint event and system.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.H6: component code 4756 was utilized because it is unknown as of the date of this report which system component attributed to the complaint event.
Event or Problem Description
Siemens healthineers was informed by its service organization regarding a malfunction associated with the artis one system.It was stated that no x-ray was possible during an emergency procedure.The patient was relocated to another system for completion of the procedure.No adverse health consequence to the patient was communicated to siemens healthineers.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported issue.The investigation was performed based on expert discussions considering complaint description, customer service reports, and system history, and system log files analysis.According to the initially provided information, no x-ray was possible during an emergency procedure.The patient was relocated to another system for completion of the procedure.No adverse health consequences to the patient were communicated to siemens heathineers.It is concluded that the relay in hospital power supply control cabinet was malfunctioning and caused a lack of power to the generator, resulting in no x-ray exposure from the system.System was back to full functionality after hospital technician exchanged the defective relay.No system malfunctions or non-conformities have been identified.The system worked as specified.No further actions are necessary.H11 corrected data: h6: the medical device problem code reported in the initial mdr submitted on december 26, 2023, should have been 4027.Code 4042 was reported in error.H6: the medical device problem code reported in the initial mdr submitted on december 26, 2023, should have been 4027.Code 4042 was reported in error.
Additional Manufacturer Narrative
On 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.; mri ctr, gaoxin c ave., 2nd,; hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri ctr, gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18392652
• Report Number: 3004754211-2023-00007
• Device Sequence Number: 2761155
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: (01)04056869009964(21)82091
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 07/18/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/29/2024; 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