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

Model Number	10094135
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred on the artis zee floor unit.A potentially high dose reading for a patient was communicated.However, detailed clarifications of this event are currently ongoing, therefore the event is reported in doubt.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.Section h6 code 4755 - unknown component.
Additional Manufacturer Narrative
The investigation was completed by our experts.The detailed log-file investigation did not reveal any system deficiencies.The analysis showed that within one hour fluoro was performed for approximately 29 minutes which resulted in 2,80gy skin dose; and 35 acquisitions taken resulted in 2,83gy.Most x-rays were taken at a water value of approximately 35cm and a source image distance (sid) of 110cm.All fluoro skin dose rate was below 88mgy/min.The applied dose was displayed to the user in real-time on the monitor.Therefore, the applied dose levels were in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements, and applied under the full control of the operator.In addition, no deficiencies could be found during a system check.Furthermore, hair loss is a known side effect for radiation emitting products which is indicated in the operator manual.No system problem could be identified.The system works as specified.

• Brand Name: ARTIS ZEE FLOOR
• 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: 18579844
• Report Number: 3004977335-2024-00008
• Device Sequence Number: 20955333
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 12/28/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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 Sex: Unknown