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

Model Number	11327700
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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.The user reported that image quality devices and the catheter are not clearly visible.There is no report of impact to the state of health of any patient or user 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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.Detailed examination of the case showed that the system had not malfunctioned and was operating according to specification.The customer service engineer (cse) directly on site could not detect any system issue.The procedure was successfully completed by the customer on the affected system.No fault was found with the system and the system continued to operate as specified.A possible systematic issue that would require 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 ICONO FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12120185
• Report Number: 3004977335-2021-87334
• Device Sequence Number: 3713410
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1