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

Model Number	11327700
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware of a system malfunction of the artis icono floor unit.The system failed to switch to the ups (uninterruptable power supply).We have no indications of adverse effects on the health status of patients, users or third parties.
Additional Manufacturer Narrative
The investigation of the reported issue revealed that the ups (uninterruptible power supply) had failed due to the customer combining the ups with the artis generator, which was not suitable for this purpose.The artis system did not cause or contribute to the situation described.The operator manual contains adequate instructions about modifications to the product.The system works as specified.

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18846327
• Report Number: 3004977335-2024-00028
• Device Sequence Number: 7757382
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown