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 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H6: multiple annex a codes were coded for this event.A12 was coded for the failed communication with pacs and dicom.A1302 was coded for being unable to upload exams.H3, h6: no products were received for 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.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 after the system was worked on, the site was unable to upload exams to electronic picture archiving and communication systems (pacs).The site confirmed that the original networking information was listed under the mobile view station (mvs) tab.Failed to upload to digital intercommunication of medicine (dicom). there was no patient involvement.
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Manufacturer Narrative
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Updated information in section e.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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Manufacturer Narrative
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H3, h6) the system was serviced in the field and it was found that the networking information needed adjustment.The system performed as intended.Codes b01, c13, and d02 are applicable.H2) concomitant medical product: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000164, serial lot: unknown.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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