It was reported to siemens that a malfunction occurred while operating the artis zee ceiling system.During an interventional procedure, the user reported that the dsa machine suddenly began leaking water from the tube water cooler.As a result, no x-ray release was possible.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
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Siemens has completed an investigation of the reported event.The root cause could not be determined.The investigation was performed considering complaint description, cs reports, and system history.The customer reported that on (b)(6) 2021, the system suddenly leaked water from the tube water cooler which led to the suspension of the normal interventional operation.The issue was resolved by an independent (non-siemens) service organization.Unfortunately, in this case, a more in-depth and verifiable analysis of the problem described in the complaint was not possible as the customer refused the onsite visit from siemens service.According to experts, a problem inside the x-ray tube cooling system is conceivable.A possible general error which would require corrective action of the installed base could not be identified by the investigation.The incident described was not classified as a reportable event after detailed investigation, because neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected, since the corresponding probability according to the risk analysis is in the range of inconceivable.
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