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

Model Number	10849000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not 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 system.During an emergency patient procedure, system movements were blocked.Additional information was provided that the procedure was continued and finished using an alternative system.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation was performed by considering complaint description, customer service reports, system history, & system log files.With start of an emergency procedure automatic system movements were repeatedly interrupted by the system.The system messages "stand/table adjustment needed, sc - move carefully", "stand/table error - use emergency stop to reset" and "limited stand/table movement, wait, robot com.Problem active" were displayed to the user.The procedure was then continued and finished using an alternative system.No health consequences were reported to this event.The onsite service intervention showed no deficiencies as the user had performed a power cycle in the meantime, which resolved the problem.Log file analysis revealed that during first system start on this day the ethernet connection between the system and the robot was briefly not established.Consequently, the robot was not properly started, resulting in the problems with the automatic movements as described.The reason why the connection was temporarily unavailable could neither be determined nor provoked.In general, the operator manual contains adequate information on how to handle movement problems (e.G., reset of the stand control unit).In addition, the displayed system messages also indicate possible remedies for the situation (e.G." ¿ use emergency stop to reset").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: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 21356102
• Report Number: 3004977335-2025-00021
• Device Sequence Number: 7835840
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 01/18/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/20/2025
• 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