MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS PHENO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10849000
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
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.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis pheno unit.During an emergency procedure, the user was unable to perform x-ray exposure.The procedure was successfully completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
H3, h6: a detailed investigation of the reported event and system was completed.The investigation was performed based on expert discussions considering complaint description, customer service reports, system history and system log files.According to the provided information, x-rays were not possible during an emergency procedure.As a result, the procedure was continued and finished using an alternative system.No health consequences were reported to this event.The investigation showed a problem with the external power supply of the x-ray generator.After replacing the leakage protection in the hospital's power distribution cabinet, the problem was solved, and x-ray was possible again.The incident described in the event is not classified as a reportable event adverse event after a thorough investigation because no malfunction of the siemens system could be detected.The system did not cause the situation described nor did it contribute to it.The system works as specified.
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 PHENO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18021687
• Report Number: 3004977335-2023-00141
• Device Sequence Number: 18037899
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)(04056869046877(21)164769
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201156
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10849000
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 07/18/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/27/2023; 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