Model Number EPIQ 7C - 795201 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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An investigation to determine the cause of this issue is ongoing.Return of the transducer is anticipated; the failure analysis will be included in a follow-up report upon its return and investigation completion.
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Event Description
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A customer reported their epiq 7c system locked up while performing a tee (transesophageal) examination using an x7-2t model transducer.During the procedure, the doctor noted minor bleeding from the patient¿s esophagus, but could not determine when or how the bleeding occurred.The procedure was successfully completed using another ultrasound system and the patient received treatment in the ear, nose and throat department.The suspect transducer has been removed from service and will be replaced with another x7-2t transducer.Further information regarding the patient condition was not disclosed.
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Manufacturer Narrative
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The suspect x7-2t transducer returned to philips for further investigation.A thorough failure analysis was performed in which the probe passed all performance testing.There were no evident signs of holes in the sheath or corrosion in the connector, and the cable was capable of articulating fully while imaging.No system lockups or error messages were triggered throughout the evaluation and after repeated attempts with multiple operators and systems, the reported issue could not be reproduced.
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Search Alerts/Recalls
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