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

Model Number	10848353
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
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
It was reported to siemens that a malfunction occurred while operating the artis q.Zen floor system.During an interventional procedure, the user reported that the image was lost.At this time, we are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.According to customer information, an implosion-like noise was heard on the c-arm x-ray tube during an interventional procedure.As a result, x-rays could not be taken and the bypass areas were displayed on the main screen.This event occurred after the positioning but before stent deployment.The procedure could also be finalized without angiographic control.The investigation revealed that the bearing of the rotating anode x-ray tube was blocked.If the anode does not rotate, the tube would overheat and destroy further tube components.For this reason, the system switches to bypass mode, in which lower radiation power is released and in which only continuous fluoroscopy with reduced image quality is available.Acquired scenes cannot be saved and reviewed.A standing rotary anode inevitably leads to the loss of x-rays.Despite all precautions, such failures cannot be completely avoided, as bearing wear depends on the respective load.After exchange of the x-ray tube the system works as intended.The spare parts consumption of the x-ray tube was checked.Any accumulation of faults of even a possible systematic error that would require a corrective of the installed base action could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q.ZEN FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forccheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12655371
• Report Number: 3004977335-2021-00471
• Device Sequence Number: 17263064
• Product Code: OWB
• UDI-Device Identifier: 04056869010014
• UDI-Public: 04056869010014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 10848353
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 01/20/2022
• 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