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

Model Number	10094135
Medical Device Problem Codes	Output Problem (3005); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During an emergency procedure, the user reported that no system movements were possible.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens conducted a retrospective review and re-evaluated this complaint.Siemens has now deemed that this complaint now meets the requirement for reporting under 21 cfr 803.Investigation showed that the joystick button of the stand control module (scm) was sluggish to operate.Dried liquid residues/ cleaning agents were found in the key guidance of the button.The table control module (tcm) was also exchanged even though no errors related to the tcm were found in the logs.Investigation of the tcm also showed that liquid/ cleaning agents had entered the module interior.A sticky substance was found below the keyboard cover frame.Considering the findings, the issue was caused by liquid contamination, which lead to a mechanical defect.It is possible that this happened during system cleaning / disinfection by the customer.The operator manual and cleaning guide contain adequate information on this topic and warn about liquids seeping into the system.The scm and tcm were exchanged as part of service activity.The occurrence rate of the error pattern was checked a possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS ZEE FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17386060
• Report Number: 3004977335-2023-53914
• Device Sequence Number: 5929325
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• 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,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 10094135
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown