MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094141
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	07/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens was informed about an incident that occurred while operating the artis zee biplane system.During an interventional procedure, a ceiling suspended lead radiation shield manufactured by a third party ¿ mavig - fell down.The procedure was continued and completed on the same unit.Detailed clarifications of this event are currently ongoing.Therefore, the event is reported in doubt.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
H3, h6: the detailed investigation of the complaint event and system was completed.During a procedure, due to a misunderstanding, it was initially thought that the x-ray protection shield fell.However, further clarification showed that a thin metal plate from the joint of a third-party support arm for the x-ray protection shield fell.The purpose of the thin metal plate is to prevent dirt from entering the joint.The thin metal plate is light and without sharp edges.The support arm could still be moved, and no adverse event was communicated after the incident.The third-party supplier was notified, and the issue was investigated.Investigation showed that the plastic cover that holds the thin metal plate was damaged, causing the thin metal plate to fall.However, it cannot be determined, how the plastic cover was damaged.The thin metal plate is removed.The incident described in the reported event is not classified as a reportable event adverse event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: ARTIS ZEE BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17583847
• Report Number: 3004977335-2023-00093
• Device Sequence Number: 12023274
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 10094141
• 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: 07/23/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/29/2023
• 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