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

Model Number	10280959
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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 zeego system.During an interventional procedure, the user reported an image problem.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.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.The detailed investigation showed two faults in a row, which ultimately caused the loss of x-ray radiation.The emitter / heating coil of the large focus of the x-ray tube vaporized small amounts of metal particles at certain points which contaminated the vacuum of the x-ray-tube which is driven by high voltage.This contamination occasionally led to high-voltage flashovers within the x-ray tube and tube arcing could be confirmed on the returned x-ray tube.Since the evaporation of the emitter material is accompanied by a reduction in its diameter, the emitter became hotter than usual.This, in turn, caused the emitter to warp mechanically until it finally touched the surrounding and put itself out of action.The unavailability of x-rays is due to the emitter touching its surroundings combined with the appearance of tube arcing.The affected x-ray tube was replaced on site by the local service organization and the error has not reoccurred.The spare parts consumption of the affected component was checked and a possible general fault that would require corrective action of the installed base could not be identified by the investigation.After 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 ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11730821
• Report Number: 3004977335-2021-75132
• Device Sequence Number: 3833158
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 10280959
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1