Model Number EPIQ CVX ULTRASOUND SYSTEM |
Device Problem
Operating System Becomes Nonfunctional (2996)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
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Event Description
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A customer reported encountering an incident where their epiq ultrasound system became unresponsive during a mitraclip heart valve procedure.The system was restarted to successfully complete the procedure.The patient was not harmed as a result of the issue.
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Manufacturer Narrative
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A thorough technical investigation was to be performed including evaluation and analysis of system logs.However, the system logs related to this event were inadvertently deleted prior to retrieval.Therefore the software engineering team was unable to reproduce the issue and the root cause of the reported event could not be determined.This issue has not recurred at the customer site since upgrading the system software.If the issue recurs, another complaint record will be generated to further investigate the problem.
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Event Description
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A customer reported encountering an incident where their epiq ultrasound system became unresponsive during a mitraclip heart valve procedure.The system was restarted to successfully complete the procedure.The patient was not harmed as a result of the issue.
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Search Alerts/Recalls
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