Model Number ACUSON SC2000 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Original submission: the customer service engineer (cse) was dispatched to the user facility and found a broken pin allowing free movement of the control panel.The cse replaced the uilk with a uilk2.Follow-up submission: additional information was received and it was reported that the reported phenomenon did not occur during an exam.It was reported as a mechanical issue which makes it awkward for the sonographer/technician to move the system from room to room.There was no patient involvement.No additional information was provided.This supplemental report is being submitted to provide additional event information, provide the date new information was received, and update the patient code.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 and fu#1 because the establishment registration id# changed since the original submissions in 2016.
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Event Description
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It was reported that the uilk pin broke off allowing free movement.This issue has been consistent since the pin had sheared.It is unknown whether the malfunction occurred during procedure.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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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 reported phenomenon did not occur during an exam.It was reported as a mechanical issue which makes it awkward for the sonographer/technician to move the system from room to room.There was no patient involvement.No additional information was provided.
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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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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 section h3), update the event problem and evaluation codes (see h6), and provide the investigation results.Investigation results: it has been found that in events of very harsh or severe steering of the system, a pin component can sheer.A new design for this feature was released that will eliminate this failure.
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Search Alerts/Recalls
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