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

Model Number	10094137
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of an unintended system movement that occurred while operating the artis zee ceiling machine.After the imaging examination was completed, the c-arm moved without given command and crashed into a patient on a wheelchair.There are no indications of any adverse effects on the health status of the involved patient.Detailed clarifications of this event are currently on-going; therefore, the event is reported in doubt.
Additional Manufacturer Narrative
The investigation of the c-arm collision with the patient in the wheelchair was completed.The user claimed unintended system movements.However, the detailed investigation did not reveal any indication for uncommanded system movements.The on-site service intervention by siemens local service showed no system deficiencies.According to the provided log files, the movement was initiated by the user.The dead man grip was pressed and the joystick on the stand control module was deflected.The operator manual contains adequate instructions about system movement and how the operator can avoid a collision, e.G., use block movement button to avoid accidental activation of system movements when the system is not intended to be used.The concerned system works as specified.

• Brand Name: ARTIS ZEE CEILING
• 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: 19656671
• Report Number: 3004977335-2024-00070
• Device Sequence Number: 6540534
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K181407
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 10094137
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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 Age: 86 YR
• Patient Sex: Male