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

Model Number	10849000
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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.Section h6: 4755 - robotic c-arm.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis pheno unit.The robotic c-arm collided with the patient table base.We have no indications of adverse effects on the health status of patients, users or third parties.Siemens has requested additional information about this event.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.To resolve the issue, siemens service organization deleted all adjustment settings, reset the stand control unit, and performed geometric re-calibration according to the instructions.All system checks, including an additional test to provoke the observed behavior, were performed without any issues.The damaged cover was exchanged as well.The investigation could not identify the root cause of the reported collision.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: ARTIS PHENO
• 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: 18886181
• Report Number: 3004977335-2024-00031
• Device Sequence Number: 2997297
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 10849000
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 03/12/2024
• 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