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

Model Number	11327600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono biplane unit.During an interventional procedure, no system movements were possible.The patient had to be relocated to a different hospital to complete the procedure.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The log file analysis showed that the system had detected a collision with the ceiling suspension of the display though there no actual collision had occurred.Consequently, further system movements were blocked for safety reasons.The onsite service intervention revealed that in june 2023 a cable jumper in the display ceiling suspension (dcs) carriage was not correctly installed, it was hanging down and became pinched between the cover and the grounded metal rail.Over the course of 10-month usage, the insulation of the cable had worn out, resulting in temporary short circuits.As cause an improper workmanship during installation could be determined.To resolve the problem, the cable at the dcs was repaired as part of service activity.This case is a single occurrence event.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: ARTIS ICONO BIPLANE
• 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: 19104891
• Report Number: 3004977335-2024-00042
• Device Sequence Number: 7682104
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 06/28/2024

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: 11327600
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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