Siemens is conducting a thorough investigation of the reported events.At this time, there is no causality between the system error and the patient's death.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.
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Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The event logfile analysis on (b)(6) 2021 showed that the system was started at 07:38 and the patient was created at 08:28.Examination was from 8:50 to 11:33 with fl/acq.No bypass and no errors were found.A siemens service engineer was onsite to check the system functionality and the affected parts by the fire.Several fire marks were seen on the table covers, lower body radiation protection and ehc cable.The system was working well from a technical point of view.The affected parts have been replaced for this system.The affected parts (table covers, lower body radiation protection and ehc cable) are designed with nonflammable materials.In this case, only minor fire marks were on the surfaces of the affected parts without further fire spread while system functionality was not affected.The customer did not raise any complaints for the artis one system during this case and confirmed that the system did not contribute/lead to the patient death.It was concluded that no malfunction occurred.The artis one system did not cause/contribute to the fire nor to the patient death, which the causal relationship between serious incident and the system have not been established.
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