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

Model Number 10094135

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

Siemens became aware of an incident that occurred while operating the artis zee floor system.During a patient procedure, the physician repositioned the radiation protection screen, and it was hit by the c-arm.This resulted in a part of the lead screen breaking off.Additionally provided information stated that the broken part of the lead screen was caught by the plastic covering of the radiation protection screen.We have no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.A supplemental report will be filed if additional information becomes available.

Manufacturer Narrative

The investigation of the reported incident did not reveal any indication of an unintended system movement.The artis zee floor system did not cause or contribute to the collision.There is no indication for a system malfunction.The described collision situation may only occur if the user does not check for surroundings and potential obstacles prior to releasing system motions.The operator manual contains adequate instructions about system movement and how the operator can avoid possible collision.The damaged live monitor was exchanged as part of the service activity.The concerned system works as specified.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 ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstr. 1- or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malrven, PA 19355 ; 4843234197
• MDR Report Key: 18152317
• MDR Text Key: 328315718
• Report Number: 3004977335-2023-00151
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1