Model Number EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/13/2020 |
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 an issue associated with the epiq ultrasound system image boost with xplane and color flow or doppler while using the x8-2t tee transducer.If image boost is enabled the color box shows flow visualization not accurately represent the fluid flow.Similarly, if image boost is enabled, both cw and pw doppler traces will not accurately represent the fluid flow.This issue occurred while imaging a patient with a known tricuspid regurgitation.The failure was identified by the user and there was no allegation that the reported issue impaired clinical judgment or affected patient outcome.
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Manufacturer Narrative
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A thorough investigation was performed by development engineering to assess the reported issue.When image boost is enabled in color xplane it was observed that the orientation of the color data was not aligned with the echo data at most seek angle settings on the a-plane.The color and echo rotation increments were specified independently, but the software design for xplane did not ensure that these were the same or detect that they were different.This created a misalignment between the planes, resulting in the ultrasound system transmitting at the wrong rotation because the seek angle settings were selecting the wrong plane orientations.A medical device correction letter was distributed to customers with systems potentially affected.The letter included specific software symptoms and initial remedy to install a software upgrade which disabled the issue boost feature.Additional corrective and preventive actions are being implemented that includes updates to applicable software design documents and associated templates to improve documentation of design elements and peer review requirements.This action was reported to fda per 21 cfr part 806 on 12/16/20.Reference corrections and removal report number 3019216-12/16/20-002-c.
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Event Description
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A customer reported encountering an incident where if the image boost feature is turned on in xplane color flow, the software fails to move the color angle when the seek angle is changed on their epiq ultrasound system.There is no allegation that the reported issue impaired clinical judgment or affected patient outcome.The customer was able to recognize the issue, which did not lead to a misdiagnosis.
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Search Alerts/Recalls
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