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

Model Number	10094135
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware of a malfunction while operating the artis zee floor unit.During an emergency patient procedure, x-ray release became unavailable to the user.The patient had to be transferred, and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported issue.The investigation was performed based on expert discussions considering complaint description, customer service reports, and system history, system log files, and c-part analysis.According to the initial provided information, x-ray was blocked during an emergency case.The procedure was then continued and finished using an alternative system.No negative health consequences to the patient were communicated to siemens heathineers.The log-file investigation showed that prior to system usage, the system displayed the message "tube hot, have a break" to the user.However, the user started using x-ray.After several x-rays, the system displayed the message "no xray, tube too hot" to the user.A defective x-ray tube cooling unit was found during the service intervention.Therefore, the heat generated by the x-ray tube could not be dissipated.To solve the problem, the cooling unit was then exchanged as part of service activity.During the investigation of the defective part by the manufacturer, the pump was found stuck.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.The cooling unit was exchanged by the local service organization.The error mentioned in the complaint has not been reported again since then.This issue has been investigated, and the failure has been identified.As of the date of this report, no field (safety) corrective action (update) is determined to be necessary.
Additional Manufacturer Narrative
7/18/2024: 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: 18208832
• Report Number: 3004977335-2023-00154
• Device Sequence Number: 6464211
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045(21)136176
• 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): 07/18/2024

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: 11/23/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 07/18/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/29/2024; 07/18/2024
• 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