MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2025
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 zee floor unit.No x-ray exposure and system movements were available during a procedure.Detailed clarifications of this event are currently on-going; therefore, the event is reported in doubt.
Additional Manufacturer Narrative
The investigation of the reported issue was completed.A detailed analysis of the log files revealed that the guard function of the footswitch , which blocks further system movements if the footswitch is jammed, was activated.The system displayed the message: ¿footswitch: guard active¿ to the user.As a result, normal system movements were blocked.However, movements were still possible at reduced speed in the override mode.A system restart, as reported, could not be confirmed, but the guard error was reset after approx.20 minutes.The on-site service intervention showed that the wireless footswitch had a critical battery voltage.The battery was nearly empty.In general, the instruction for use provides adequate information on how to act in such situation, e.G.System movements with activated guards, release of x-ray with a wired footswitch or the hand switch available on the system.Furthermore, the operator manual states that the batteries of the wireless footswitch should be charged before starting the examination.In case of empty batteries, the provided power adapter should be used to continue the procedure.The battery charge status is shown as three leds at the footswitch.The system was installed in 2010 and had already reached end of support (eos).It has since been deactivated and dismantled, therefore, further in-depth investigation is not possible.Based on the available information, expert opinion and the information provided, it is deduced that the wireless footswitch was nearly discharged and caused the described system behavior.The occurrence rate of the aforementioned error pattern was reviewed.The investigation could not identify any error accumulation or systematic issue that would require corrective action for the installed base.

• Brand Name: ARTIS ZEE FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemenstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 22158853
• Report Number: 3004977335-2025-00072
• Device Sequence Number: 7421991
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 10094135
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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