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

Model Number	10094135
Medical Device Problem Codes	Circuit Failure (1089); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis zee floor unit.During an interventional procedure for transcatheter aortic valve implantation (tavi), no x-ray exposure was available.The patient had to be moved 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
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be filed if additional information becomes available.Section h6 4755 - component is unknown.
Additional Manufacturer Narrative
The initial malfunction occurred on the artis zee floor unit on march 6, 2024.The on-site service interventions following the incident showed a ¿potential write performance issue¿ indicating an problem with the image disk and/or the copra board.Therefore, the image disk and the copra board were replaced as part of service activity.However, the issue re-occurred on may 15, 2024, (mdr # 3004977335-2024-00059) during a heart replacement procedure.There were no health consequences associated with this event.Further detailed investigation showed sporadic issues with the sas (serial attached scsi) controller.The sas controller serves as the interface between storage devices and the computer's motherboard, facilitating data transfer between them.The log-file showed that when the x-ray was performed, the image file system component in the image acquisition system (ias) was not able to write x-ray data on the image drive due to a timeout failure.Furthermore, system event log showed a sas controller error for the image drive.Subsequent, the system was not able to produce x-ray.To prevent any further recurrences, the entire image acquisition system pc was replaced on may 23,2024.However, the investigation did not identify any hardware problems.The system was kept under observation for approximately 2 months.The error has not reoccurred.Clear root cause of the issue could not be determined.According to the experts, a contact problem was the most likely cause of the observed behavior, which may have been remedied by vibrations during transport.The primary udi number in section d4 was corrected.

• 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: 18932911
• Report Number: 3004977335-2024-00033
• Device Sequence Number: 14587825
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045(21)135328
• 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
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 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