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

Model Number	10849000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis pheno unit.When patient was in trendelenburg cradle position right side down, the user was trying to switch beds but at breakpoint the bed slipped out and the patient fell to the floor.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
During an emergency procedure, as the sedated patient was being positioned into "trendelenburg" (with table tilt and cradle adjustments), the tabletop detached and fell while the patient remained strapped to it.The head of the tabletop made contact with the ground, while the foot end stayed on the table, leaving the patient in a downward diagonal position but not in direct contact with the floor.No health consequences were reported to this event.The procedure was then continued with an alternative system.The investigation was conducted in expert discussions (considering complaint description, cs reports, system history, system log files).A detailed investigation showed that when the tabletop was moved into the trendelenburg position, it made contact with something beneath the table, likely during the tilting motion.This caused the tabletop to lift upward while the table base continued to tilt.As a result, the two locking bolts on the underside of the tabletop were raised out of their holes in the table base (with the tabletop inclined about 3 degrees).The tabletop continued to lift, and at around 5 degrees inclination, the tabletop disengaged at the foot-end from the holding notch in the table base.At this point, the tabletop was no longer securely attached and could slip from the base.This issue was hidden by the drapes and was not immediately noticeable to the customer.The system is designed to block all movement immediately when the tabletop started to lift away from the base, triggered by the activation of the tabletop proximity switch.During the onsite service intervention, it was found that the tabletop proximity switch had been immobilized by contrast medium residue, preventing it from functioning.Consequently, no error message was displayed to indicate improper tabletop fitting, nor was table movement blocked.Daily checks include verifying the sensor¿s function.Log-file analysis revealed that the required daily system check was not performed, so the user did not detect the malfunction of the table sensor.This incident has been identified as an isolated occurrence, caused by the following sequence of events: the table sensor became stuck due to being heavily soiled with contrast agent and not being cleaned.The requested daily check was not performed according to the instructions in the operator manual; the customer did therefore not notice the malfunction of the table sensor.The table was lowered onto an object.The misalignment between the tabletop and the table base was not noticed because the affected area was covered.To resolve the problem, the proximity switch on the table base was thoroughly cleaned, and the tabletop was reinstalled.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• 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: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 24116008
• Report Number: 3004977335-2026-00009
• Device Sequence Number: 18484565
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 01/11/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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