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	12/13/2023
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 on incident that occurred while operating the artis pheno system.An unintended c-arm collision occurred with the table.Additional information was provided that the collision resulted in mechanical damage of the c-arm.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
A detailed investigation of the provided log files revealed that the system displayed a message "collision with table" and sounded an alarm signal right before the actual collision occurred.Furthermore, the collision occurred during a user-controlled system movement in the ¿override mode¿.The ¿override mode¿ is an optional mode where collision protection is deactivated, and system can only be moved manually at slow speed.The message ¿collision detection manually disabled - move carefully¿ is displayed to the user when using the ¿override mode¿.As the user did not stop the movement, the collision occurred, and all system movements were then stopped by the device as the gear torque exceeded the allowed limit for safety reasons (safety stop).To resolve the collision, the user manually moved the table away from the c-arm by unlocking the table brakes.Then, normal system movements were possible again.The cover of the c-arm got damaged by the collision and was repaired during service activity.It could not be determined by the investigation why the user moved the system in the override mode.There is no indication for an unintended system movement.No system deficiencies could be determined causing or contributing to the collision.The system worked as specified.In general, it is in the responsibility of the operator to check for potential collisions before releasing system motions.The operator manual contains adequate instructions about system movement and how the operator can avoid a collision.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.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because no malfunction of the system could be detected.

• 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: 18516427
• Report Number: 3004977335-2024-00003
• Device Sequence Number: 6779539
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 01/09/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/05/2024
• 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): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown