Model Number BI70002000 |
Device Problems
Failure to Transmit Record (1521); Application Program Problem (2880); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
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: bi71000907, serial/lot #: -, ubd: unknown, udi#: unknown h3, h6: the system was serviced in the field by a medtronic representative.The mobile viewing station (mvs) computer was replaced, and the rep worked with the picture archiving and communication system (pacs) admin to confirm connection.The rep sent several files to pacs over network.A system checkout completed and system is operational.Codes b01, c07, and d02 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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 the system was "still" having issues sending exams to picture archiving and communication system (pacs).The site stated that when trying to send multiple exams at once, a transfer failed message will appear and they can sometimes send the exams individually but a lot of the time it fails.They also stated that only axial exams ever went through and not coronal or sagittal, even when they are selected.They stated that the issue was occurring in 3 ors, and networking information had already been confirmed by the pacs administrator.The site representative did not know what additional troubleshooting had been done and was not with the system to test the connection while on the phone.There was no patient involvement.
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Manufacturer Narrative
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H2: concomitant product bi71000907 lot #: 2435377 rev.D h2, h3, h6: the returned mobile viewing station (mvs) server was analyzed.No failures were found.Codes c19 and d14 are applicable, as is previously reported code b01.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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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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Additional information was received.This was not previously reported by the site.It was unknown when or how many time it had occurred prior.
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Search Alerts/Recalls
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