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

Model Number	10849000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will submitted if additional information becomes available.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis pheno unit.During an interventional patient procedure, no table movements were available.Additional information was provided to siemens stating that the patient passed away.It is unclear whether the device performance contributed to the patient¿s death.Siemens has requested additional information and is conducting an investigation.
Additional Manufacturer Narrative
During a leadless pacemaker implantation procedure on (b)(6) 2026, the user reported that the patient table could not be repositioned using the table-side control module - tcm-s (table-side control, servo assisted) - resulting in reduced ability to maintain visualization during catheter and sheath removal.The procedure reportedly progressed without incident until the removal of the delivery catheter and vascular sheath.At that point, the patient experienced sudden clinical deterioration and passed away.Device log file analysis identified intermittent malfunctions of the tcm-s, which were also displayed to the operator as error messages.Analysis of the returned product confirmed a defect in the tcm-s, including mechanical damage to a control button and sensor irregularities affecting signal generation.The tcm-s and associated cables were replaced by siemens local service, and no further issues were observed following the repair.Other system control pathways - including tcm-j (table-side control with joystick), pilot module, and detector controls - were available and functional during the procedure; however, log-file information indicates that these control pathways were not used.The impact of the tcm-s malfunction on procedural decision-making and visualization during catheter and sheath removal could not be fully determined based on the available information.Clinical data indicates that a severe vascular injury during sheath extraction is a plausible cause of death.A direct causal relationship between the device malfunction and the patient outcome could not be definitively established based on the available evidence.

• Brand Name: ARTIS PHENO
• 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: 24305222
• Report Number: 3004977335-2026-00021
• Device Sequence Number: 14781172
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown