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

Model Number	11327600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the reporting facility phone number is (b)(6).H3, h6: siemens healthineers has initiated a detailed investigation of the complaint event and system.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Event or Problem Description
Siemens healthineers was informed by its service organization about an issue with the artis icono biplane system.The display ceiling suspension support broke and partially detached from the ceiling.There was no report of any adverse health effects to the patient, users, or third parties.
Additional Manufacturer Narrative
On (b)(6) 2024, the display ceiling suspension (dcs) was accidentally caught with a serum holder rod attached to the table's accessory rail.When the customer moved the table down to prepare it for the next patient, the table bent the dcs downward.No health consequences were reported to this event.According to the information provided, the profile attached to the ceiling on the foot side, to which the dcs is attached, did not withstand the additional force caused by the serum holder and the table movement.The investigation revealed that one of the two screws holding the profile to the ceiling on the foot side was apparently defective.This meant that only one screw was holding the increased load on the foot side.This screw remained attached to the ceiling concrete, but the washer and the fixing hole of the profile were deformed by the heavy load, and the back of the dcs support plate including the dcs bent.The dcs did not fall down completely as the profile on the head side remained intact.To resolve the issue the profiles were replaced and fixed according to specification.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action 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 HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20501052
• Report Number: 3004977335-2024-00124
• Device Sequence Number: 7245351
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K230950
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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