Model Number EPIQ CVX DIAGNOSTIC ULTRAOSUND SYSTEM |
Device Problems
Operating System Becomes Nonfunctional (2996); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2021 |
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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The customer reported an incident where their epiq ultrasound system displayed an error message that required a system restart to recover.The error occurred 3 times during a mitral clip procedure while using an x7-2t model transducer.There was no allegation of patient or user harm as a result of the issue.However, the issue caused a 20 minute delay in the procedure.
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Manufacturer Narrative
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A thorough investigation was performed to identify the root cause of this issue, including an evaluation and analysis of the logs from the ultrasound system and customer workflow.The software engineering team could not reproduce the issue as described by the customer.However, the reported error message indicates the displayed values being out of system parameter limits, and not the actual value used by the system.A philips applications specialist went to the customer site with a workflow workaround and no additional issues were observed during onsite testing and monitoring.The system has been placed back into service with no additional complaints regarding this issue reported by the customer post resolution.
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Event Description
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The customer reported an incident where their epiq ultrasound system displayed an error message that required a system restart to recover.The error occurred 3 times during a mitral clip procedure while using an x7-2t model transducer.There was no allegation of patient or user harm as a result of the issue.However, the issue caused a 20 minute delay in the procedure.
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Search Alerts/Recalls
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