Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM |
Device Problems
Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2021 |
Event Type
malfunction
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Event Description
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A customer reported their epiq cvx ultrasound system shut down with an error message during use on a high risk patient.The procedure in progress was completed successfully using a different ultrasound system available at the customer site.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 philips service engineer is scheduled to retrieve the system logs at the customer site.Evaluation of the logs will be included in a follow up report upon investigation completion.
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Event Description
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A customer reported their epiq cvx ultrasound system shut down with an error message during use on a high risk patient.The procedure in progress was completed successfully using a different ultrasound system available at the customer site.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 of the event was to be performed; however, no system logs were received and are not expected to be received.The engineer reloaded the software and was unable to duplicate the failure.The system is back in clinical use at the user¿s facility.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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Search Alerts/Recalls
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