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

Model Number	10094135
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction while operating the artis zee floor system.During a pacemaker implantation procedure, the system automatically shut down due to a power supply problem.It is unclear if the pacemaker was successfully transplanted before the issue occurred.Detailed clarifications of this event are currently on-going; therefore, the event is reported in doubt.We have no indications of any adverse effects on the health status of the involved persons.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
A detailed investigation revealed a failure of the "24v power supply u1" after more than 10 years of operation.As a result, the can (area network controller) switched off and caused the system to shut down.The affected part was exchanged as a part of the service activity, which resolved the problem.The spare parts consumption of the defective ¿24v power supply u1¿ was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.
Additional Manufacturer Narrative
7/17/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: ARTIS ZEE FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: 17976540
• Report Number: 3004977335-2023-00134
• Device Sequence Number: 11376013
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045(21)137121
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 10/13/2023
• Supplement Date Received by Manufacturer: 02/05/2024; 07/17/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 02/05/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 64 YR
• Patient Sex: Male