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	Insufficient Information (4580)
Date of Event	09/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis pheno system.During an emergency procedure, no x-ray release was available.The patient had to be moved to complete the procedure on an alternate unit, however, the procedure was delayed.The patient subsequently expired.The relationship between the system failure and the patient death is unknown at this point in time.Siemens has requested additional information for this event.
Additional 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.
Additional Manufacturer Narrative
H3, h6: siemens completed the detailed investigation of the reported event and system.The investigation was performed based on expert discussions considering the complaint description, customer service reports, and log file analysis.According to provided information, during an emergency procedure for an aortic rupture in a 91-year-old man, the system movements and the x-ray were blocked.A system reboot did not solve the problem at hand.Immediate open surgery could not be performed due to the system position (above the patient).The emergency rescue functionality was not used because users were not aware of this function in this extreme situation.Subsequently, the patient was pulled off the table without the c-arm being moved away and transferred to the nearest available operating room.Unfortunately, the patient died during the surgery.The log file analysis revealed that the circuit-board mca_basic_switch had malfunctioned.This switch is the main component that connects the ccom (central computing) and the iob (input output box) via the srio (digital high-speed interface) as well as other components.With the loss of the srio connection, x-ray and system movements were blocked.The investigation of the circuit and the board layout of the malfunctioning part showed a failure of the step-down regulator ltc3418.This ic-component did not provide an output voltage for the srio and led to the failure of the srio connection.According to the other equipment manufacturer (oem), as well as a "similar case" analysis, this defect was observed for the first time.Therefore, a possible error accumulation, which leads to a corrective action of the installed base, could not be determined by the investigation.The mca_basic_switch was exchanged as part of service activity, which resolved the problem.The complaint has been closed.
Additional Manufacturer Narrative
H3, h6: additional investigation conclusion: how to use the rescue function is adequately described in the operator manual and part of the training provided to the customer.However, how to support the user in such critical situations will be further evaluated for possible future improvements.

• 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 HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17737143
• Report Number: 3004977335-2023-00114
• Device Sequence Number: 6059894
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

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: 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 10/30/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/27/2023; 10/30/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown