Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
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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A customer reported their epiq 7c ultrasound system would not offer the xplane functionality and the acquire button would not respond with an x8-2t transducer during a watchman mitral valve procedure.The system was exchanged for another epiq unit to complete the procedure and there was no allegation of altered patient outcome as a result of the issue.
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Manufacturer Narrative
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A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information able to be obtained, the engineering team was unable to determine the root cause of this failure.The system software was reloaded and the cables were reseated to resolve the issue for the customer.No additional similar issues have been reported since this repair.
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Event Description
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A customer reported their epiq 7c ultrasound system would not offer the xplane functionality and the acquire button would not respond with an x8-2t transducer during a watchman mitral valve procedure.The system was exchanged for another epiq unit to complete the procedure and there was no allegation of altered patient outcome as a result of the issue.
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Search Alerts/Recalls
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