Model Number BI70002000 |
Device Problems
Failure to Transmit Record (1521); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000164, h6: multiple fdd/annex a codes were coded for this event.A12 for the intermittent pacs communication.A1302 for the image transfer issue.H3, h6: no products have been received by the manufacturer for analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that when attempting to both 2d anterior posterior (ap) and lateral (lat) images to electronic picture archiving and communication systems (pacs), only one image would appear on the pacs end.When sending one image, that one image would appear.Also, the site claimed that when opening an ap image on the pacs end, it would open the lat scan, and vice versa.There was intermittent pacs communication. there was no patient involvement.
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Search Alerts/Recalls
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