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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIQ CVX; GENERAL ULTRASOUND IMAGING SYSTEM, LINE-POWERED
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EPIQ CVX; GENERAL ULTRASOUND IMAGING SYSTEM, LINE-POWERED Back to Search Results
Model Number 795231
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
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.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.
 
Event Description
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 representing 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 during a mitra clip heart valve procedure.Due to the displayed imaging results after placing the mitral clip, the procedure was aborted without a permanent clip placement.
 
Manufacturer Narrative
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.
 
Event Description
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 representing 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 during a mitra clip heart valve procedure.Due to the displayed imaging results after placing the mitral clip, the procedure was aborted without a permanent clip placement.
 
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Brand Name
EPIQ CVX
Type of Device
GENERAL ULTRASOUND IMAGING SYSTEM, LINE-POWERED
MDR Report Key11051341
MDR Text Key225777578
Report Number3019216-2020-00128
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838088658
UDI-Public00884838088658
Combination Product (y/n)N
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number795231
Device Catalogue Number795231
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date12/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3019216-12/16/20-002-C
Patient Sequence Number1
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