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Model Number ACUSON SC2000 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/21/2016 |
Event Type
malfunction
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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.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.Background: - the issue was created in 4.0c as a side effect of a 4.0c enhancement to remove an informational message on tee probes.- prior to 4.0c, when tee probes reached 40 deg c, a popup message was displayed to inform the user the transducer temperature was rising.- on z6ms probes, the customer complained that this message was undesirable and confusing as it was assumed to be a warning message and not just informational.It was requested to be removed.Root cause: - in the 4.0c release, when the popup message was removed, the sw changes did not cover one behavior interaction with the mouse cursor.- in previous versions of sw, when the popup message was displayed, it contained an "ok" button for the user to dismiss the message.To enable the user to interact with the "ok" button, the sw provided the user with a mouse pointer.This was fixed as an engineering defect for release vb10d (4.0d) which corrects the issue, via update program us014/16/s.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial submission, fu#1 and fu#2.
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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 there was an intermittent issue regarding the transducer.When it is moved in 4d mode, the cd box works; however, when switched to 2d mode, it won't move.When going back into 4d mode, the cd box can't be moved.Reportedly, the system need to be rebooted to recover.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.
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Search Alerts/Recalls
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