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

Model Number	10094137
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis zee ceiling system.During an emergency procedure, an error message regarding the x-ray tube was displayed.Furthermore, interval warning sound was heard as well.The patient was relocated to a different hospital to continue with the procedure.The 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
The investigation was performed on expert discussions (considering complaint description, cs reports, system history, system log files).The onsite service intervention showed a defective ¿k2¿-relay in the control cabinet, which controls the power to the cooling system.As a result, the power supply of the cooling unit and the oil pump of the x-ray tube failed, causing the loss of x-ray imaging functionality.To resolve the problem, the relay was replaced, and the reported error has not re-occurred.The occurrence rate of the 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.

• Brand Name: ARTIS ZEE CEILING
• 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 HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843274197
• MDR Report Key: 17699144
• Report Number: 3004977335-2023-00108
• Device Sequence Number: 6631922
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 10094137
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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