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

Model Number	11327700
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
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 icono floor system.During an interventional procedure, the user reported that no system movements were possible.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
The log files showed that the encoder of the floor stand base rotation motor had a hardware problem and, therefore, no valid position data could be transmitted to the controller.As a result, movements of this system were prevented.To resolve the reported issue, the parts of the floor stand (motor with the encoder, the encoder cable, and the "smc" module) were replaced by local service.Following the final adjustment, the system works as specified.The motor of the base rotation returned for further examination was installed on a test unit.However, during testing no fault could be found on the motor, as the encoder values were readable.Based on the analysis result, it could be concluded that a defective cable was the cause of failure.Siemens is not aware of similar events in the field.

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, 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: 12750353
• Report Number: 3004977335-2021-00982
• Device Sequence Number: 1442316
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 11327700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/22/2021
• 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