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

Model Number	10094139
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
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 zee multi-purpose system.During an interventional procedure, the user reported that the system stopped fluoro and acquisition.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 that the error was due to a hardware problem of the generator.The t3 transformer of the generator had a defect which led to the unavailability of x-rays on site.Such a defect can only be countered by appropriate service intervention and the replacement of said component.The transformer was replaced by a siemens service engineer and the system works as specified.The occurrence rate of the fault pattern and the spare parts consumption of the transformer were checked and 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.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 ZEE MULTIPURPOSE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12347749
• Report Number: 3004977335-2021-93406
• Device Sequence Number: 4766392
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/20/2021

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: 10094139
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1