Model Number 10094135 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2017017.(b)(4).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.
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Event Description
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It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During an interventional procedure, the user reported the real time controller was not able to communicate and an error message appeared.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
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Manufacturer Narrative
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Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware failure.The investigation was performed on relevant hardware and additional information (i.E.Complaint description, log files, system history).The log file analysis showed that the system lost and regained connections to several sub components.As a result, the release of x-ray was practically blocked.This indicates an issue with the angio x-ray communication system (axcs) ethernet switch.The customer service employee replaced the damaged ethernet switch as well as the network cable.After hardware replacement there were no further issues reported.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.
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Search Alerts/Recalls
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