MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ICONO FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	11327700
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h5 code e2402 - patient passed away due to health complications.Siemens is conducting a thorough investigation.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens was informed about a system malfunction that occurred on the artis icono floor unit.Additional information was provided that the issue occurred during an emergency procedure, and the patient passed away during the procedure.Based on the information provided by noma (b)(6), the patient¿s health outcome was not related to the functional failure of the equipment.Siemens has requested additional information regarding this event to conduct a thorough investigation.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.According to the available information, a 69-year-old female patient suffered a refractory cardiac arrest one hour after a coronary intervention with stent implantation and was immediately brought back to the cath lab room, where the procedure had been performed while cardiopulmonary resuscitation (cpr) was continued.Cpr continued while the patient remained on the angio table.Unfortunately, resuscitation was unsuccessful.A coronary angiography performed on the angiosystem showed an acute stent thrombosis, which was later confirmed at autopsy.In connection with this case, a database synchronization issue was reported.The detailed log file investigation revealed that there was an issue with patient registration, when the patient was transferred to the cath lab for the second time.It was determined that the issue was caused by the on-going patient case being closed simultaneously (within 3 seconds) on the sensis and artis icono floor systems.There are two options to close a patient case.Either in the database of the artis angiography system, or the hemodynamic registration system such as sensis.Closing the patient case from any of the two systems will cause for the current patient case to close on both artis and sensis systems.As the patient case was closed on sensis and artis systems simultaneously, it triggered multiple requests to close patient cases leading to retaining new workflow ids, while not being able to proceed with a new case registration.System movements and imaging remained fully available on both units.However, the system was not used during the timeframe when the patient was put onto the table until the patient deceased.Approximately 20 minutes after the patient¿s death, the system was used, and the reported database synchronization issue occurred.The error message ¿database synchronization pending, 1 scenes left¿ was displayed to the user.System movements and imaging functions were still available.The instruction for use (ifu) provides adequate guidance on how to proceed in such scenarios.Normal system behavior returned following three manual patient registrations.A shutdown and restart of the angio system, as recommended in the ifu, would have brought back the system to normal operation as well.There is no indication that the system¿s behavior caused or contributed to the patient¿s outcome.The system was in normal operation mode during patient¿s stent implantation and was not used when the patient was in critical condition.In addition, the basic system functions remained fully avaible to the user.
Additional Manufacturer Narrative
To conclude the investigation of the report event, siemens confirms that the basic system functions of the artis icono floor remained available to the user.The imaging function was subjected to the restriction making it not possible to transmit acquisitions to image visualization system (ivs) online.However, review was still possible in the exam room with direct radiography, digital subtraction angiography, cardiac acquisition, examinations of the heart and acquisition and fluoro.In such cases acquisition images would be transferred offline to ivs once ivs becomes ready.

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; 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: 23849285
• Report Number: 3004977335-2025-00147
• Device Sequence Number: 9835598
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: (01)04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K241572
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 11327700
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 03/03/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/02/2026; 03/03/2026
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown