Model Number EPIQ 5 DIAMOND SELECT |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Information has been received from the customer to begin the investigation.Additionally, a philips service engineer is scheduled to retrieve the system logs at the customer site.Evaluation of the logs and investigation results will be included in a follow up report upon completion.
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Event Description
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A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.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 customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.The manufacturer requested the system logs from the customer for evaluation.A thorough investigation was performed by development engineering who identified a difference between the customer¿s expectations and the calculations of the average values for umbilical artery, mca and duct venosus performed by the epiq system.The manufacturer concluded the device work as intended.The system is currently in use at the customer site with no additional similar issues reported.
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Event Description
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A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.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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