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

Model Number	10094139
Medical Device Problem Codes	Defective Component (2292); Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens service organization reported that fluoro radiation values during constancy check on the artis zee multi-purpose system were too high.Higher radiation dose was detected during testing due to a defective focus.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 of the reported issue was completed by our experts with the following results.The root cause of the deviation was identified as a defective small focus of the x-ray tube.Following the replacement of the defective x-ray tube, the constancy test was passed.The x-ray tube is equipped with a large and a small focus.To be able to continue with radiation exposure and patient treatment in the event of a defect focus, the system switches to a functioning focus.However, the replacement focus has different performance data, which then affects the selection of other exposure parameters (tube voltage, tube current, exposure time, copper filter) in the constancy test.As a result, the constancy test is not passed.During normal system use while performing a procedure, such an error is displayed to the user with the error message "small focus defect, sc".The instructions for use contain adequate instructions for this scenario.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 incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: ARTIS ZEE MULTI-PURPOSE
• 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 ; 4843234197
• MDR Report Key: 17343695
• Report Number: 3004977335-2023-00059
• Device Sequence Number: 6941552
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 10094139
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown