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

Model Number	11327600
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the artis icono biplane system.Information was reported to siemens on (b)(6) 2024, that a patient was admitted to the hospital with a potential stroke.According to the physician, the patient was not in a life-threatening condition.During examination it was determined that the patient was suffering from a vascular malformation in the brain that was causing massive bleeding.The user took 3d images for a neurosurgical or, however, the images could not be found on the machine, resulting in a system delay.The unit was rebooted, and the patient was re-scanned and taken into the or.The surgery was successful and 90% of the vascular malformation was embolized.The patient is currently intubated in the intensive care unit.Due to the vascular malformation in the brain causing massive hemorrhage in the left central region of the brain, the patient has right-sided paralysis and will remain in a handicapped state.According to the treating physician, the patient¿s health outcome is not related to the system delay.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.According to the user, a patient was administered with hemiplegic symptoms and speech disorder.It turned out that the patient was suffering from massive bleeding in the brain due to a vascular malformation in the brain.A ¿3d-acquisition dct¿ for neurosurgical operation and planning was decided.The user could not find the images made with dct.After system reboot and rescanning, the patient was brought into operation room (or).Surgery went well and the vascular malformation was 90% embolized.However, a right-sided paralysis will remain.Further treatment is carried out according to the patient's clinical picture.The physician stated that the patient¿s health outcome is not related to the system deficiency.The patient¿s health consequences are the result of the underlying disease and not of the product defect.The investigation revealed that the issue was observed after merging emergency patient data (syngo-application) with data from the radiology information system (ris) patient.As per the experts, this is identified to be a syngo application issue on the image visualization system (ivs) side.Movement of pixel files to the syngo database failed and files are kept in the ivs image drive.Images will not be displayed in the patient browser immediately but after 2-3 minutes.The message ¿synchronizing database.- 1 scenes left¿ is displayed to the user.However, 3d images were not displayed, and could be recovered from the ivs image drive by service only.It could be determined that manual ivs application restart (as in the present case) or new patient registration will recover normal functions.3d acquisition images will be stored successfully then again.This is the first time that this failure scenario has been reported.No similar cases are known, nor could this error be reproduced.The occurrence rate of the error pattern was checked and 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.After detailed investigation, the incident is not classified as a reportable event as the health consequence reported is not related to the product defect.Neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ICONO BIPLANE
• 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18767203
• Report Number: 3004977335-2024-00023
• Device Sequence Number: 12688075
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193326
• 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): 03/25/2024

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: 11327600
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/25/2024
• 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 Sex: Unknown