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Model Number EPIQ CVX ULTRASOUND SYSTEM |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
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, midway through a watchman cardiac procedure, the epiq cvx ultrasound system generated a 200 error code, the user selected okay to clear the display box and the system shut itself down.The user then replaced the system to complete the procedure.The field service engineer evaluated the system and replaced the fusion acb 4 board assembly, and the error has not reoccurred.There was no patient or user harm associated with this event.
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Manufacturer Narrative
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The system logs were received, and an investigation was performed.However, the reported failure was not reproducible, and the customer confirmed there was no recurrence after the system software upgrade.
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Manufacturer Narrative
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An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.
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Search Alerts/Recalls
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