MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ICONO FLOOR; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	11327700
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis icono floor system.The user reported an intended system movement with the patient on the table.This resulted in patient sliding off the table.Siemens has requested additional information in order to conduct an investigation of the reported event.There are no indications of any adverse effects on the health status of the involved patient.The reported event occurred in the united kingdom.
Event or Problem Description
Clarification/correction: during an interventional procedure, the tabletop was tilted and then moved towards the head end with motor assistance.The user stated that this movement was abrupt and that the patient slid on the table but did not fall off the table.
Additional Manufacturer Narrative
H10: manufacturer narrative: siemens healthcare completed the investigation of the reported event.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, event simulation, and system log files.It was initially reported that during an interventional procedure, the tabletop was tilted and then moved towards the head end with motor assistance.The user stated that this movement was abrupt and that the patient slid on the table but did not fall off the table.Detailed investigation could not confirm the communicated system behavior.During an on-site service visit, various movements of the table were performed in the horizontal and inclined directions at different angles and heights with and without a load.No abrupt movements could be reproduced.No defects were found in the associated hardware, profinet and motor control interface.The investigation of the system log file revealed no indication of a system malfunction, such as an abrupt movement or an unintended movement.Neither a software simulation of the scenario on a test system in the factory could reproduce the described system behavior.In general, the tabletop is not designed to prevent a patient from sliding/falling when not fastened as described in the system user manual.The entire process of patient fixation is the responsibility of the system operator.This includes the tabletop, mattress, fixation accessories, alignment of the material and the patient on the table, and proper execution or fixation performed by the operator.The operator is also responsible for the observation of the patient during the examination, with special consideration regarding the patient's abilities (e.G., ability to respond).The instructions for proper system use including patient securement/fixation during an examination are provided with the system operator manual.The complaint issue reported by the customer could not be confirmed during the investigation.The issue mentioned in the initial complaint has not been reported again by the customer.A system malfunction was not detected during the detailed investigation.H11 corrected data: b5: clarification and correction.The patient did not fall off the table.B2: "other or serious or important medical events" was checked in error in the initial report submitted to the fda on november 16, 2022.This field should have been blank.G2: report source "user facility" should not have been checked in the initial report.This was not a user facility mdr.Report source "health professional" should have been checked.Report source "other" should have been checked and great britain listed in the corresponding field.H3: device had not been evaluated by manufacturer when the initial report was submitted.This field should have been checked "no" in the initial report.

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim,, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15807381
• Report Number: 3004977335-2022-50021
• Device Sequence Number: 5622970
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 11327700
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown