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

Model Number	11327600
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono biplane system.During an emergency procedure, the user was unable to release x-ray and the patient was relocated to an alternate unit.However, the patient's condition deteriorated, and the procedure was eventually aborted.It was later reported that the patient passed away.The causal relationship between the system failure and the patient¿s condition is unknown at this point in time.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.Section h6 code 4755 - unknown component.
Additional Manufacturer Narrative
The investigation was performed with complaint description, customer service reports, system history, log file analysis, replaced part analysis.During an emergency procedure, no x-ray was available.A mobile c-arm from a third party was used but was not sufficient.Therefore, a patient relocation was planned, however, due to the patient¿s condition, the relocation was not possible.Unfortunately, the patient has passed away.Further investigation into the health consequence of the patient was not possible as further clinical information was not provided.Log file analysis showed that there was an issue between the communication of the system and the modality computing architecture (mca) flat detector receiver (fdr) board, a main component in the image pipeline.The main task of the mca fdr board is to receive images from the flat detector and send it to the next node.This means that if there are communication issues with the mca fdr board, no x-ray is possible.It was suspected that the issue lies either with the mca fdr board or the bus assembly tca backplane.The bus assembly tca backplane is responsible for connecting various parts of the mca.Therefore, the mca fdr board and the bus assembly tca backplane were exchanged and the issue was resolved.The replaced parts were investigated, the issue could not be reproduced.Nevertheless, based on expert opinion, the root cause is determined to be a sporadic issue within the mca fdr board.As per latest information, no further issues nor repeated issues were communicated.The occurrence rate of the 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 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: jenna keefe ; 40 liberty blvd; malvern, PA 19355 ; 4843234206
• MDR Report Key: 19351228
• Report Number: 3004977335-2024-00054
• Device Sequence Number: 7109655
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317(21)180351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 05/14/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown