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Model Number ACUSON X700 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/24/2016 |
Event Type
malfunction
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Event Description
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As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that during a long and difficult transesophageal echocardiography (tee) examination, the ultrasound system crashed with a display of us_img_57 error message.The system made a beeping sound and the sonographer performed a hard shut-down.The images taken were reportedly stored.There is no report of the patient's outcome.No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of a potential adverse event and without patient outcome information.Should we receive further information in regards to this report, we will file a follow-up report.
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Manufacturer Narrative
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Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up #1 narrative: this supplemental report is being submitted to provide additional event information, provide the date new information was received, and update the patient code.As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/03/16.Additional information was received and it was reported that the transesophageal echocardiography (tee) study was not repeated.The same equipment was used to complete the study.There was no patient injury reported.No additional information was provided.Follow-up #2 narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.And the software may not detect any response from the v5ms transducer in a given time period in cw mode, since it would take a longer time to take response when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial submission, fu#1 and fu#2.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional event information, provide the date new information was received, and update the patient code.
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Event Description
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As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/03/16.Additional information was received and it was reported that the transesophageal echocardiography (tee) study was not repeated.The same equipment was used to complete the study.There was no patient injury reported.No additional information was provided.
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Manufacturer Narrative
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This supplemental report is being submitted to update the device available for evaluation (see d10), update the follow-up type (see h2), update the device evaluated by manufacturer (see h3), update the event problem and evaluation codes (see h6), and provide the investigation results.During the investigation, it was determined that the error could occur when the customer changes the angle of tee while moving cw roi simultaneously.And the software may not detect any response from the v5ms transducer in a given time period in cw mode, since it would take a longer time to take response when cw roi is being repositioned.A solution was implemented via software releases for the x700 products.
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Search Alerts/Recalls
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