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

Model Number	10094135
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction while operating the artis zee floor unit.During an emergency procedure, no fluoro was possible, which resulted in bad image quality.The patient had to be moved and the procedure was completed on an alternate system.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.
Additional Manufacturer Narrative
Investigation of the reported issue showed that the x-ray imaging with small focus was partially defective.Consequently, fluoroscopy was often aborted often.This means that fluoroscopy with the small focus functioned to a limited extent, however, the automatic switch to another focus was not initiated.A manual switch to the large focus x-ray imaging can be performed by the user at any time, and it is described in the instructions for use.The x-ray tube was examined, and it was found that the small focus was outside the geometric limits.Following the exchange of the x-ray tube, the system works as intended.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.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 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: 19018487
• Report Number: 3004977335-2024-00037
• Device Sequence Number: 7939251
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 03/25/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/12/2024
• 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