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Model Number 9733346 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Onsite functional and visual examination was performed by a manufacturer representative.The computer was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.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 device being used outside of a procedure.It was reported that the customer reported that the image acquisition system (ias) does not boot up.The ias monitor showed the start up screen.The representative instructed the customer to access the iass computer through mstsc, but the remote desktop could not connect to the computer.
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Manufacturer Narrative
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H2) initial reporter received the last name is unknown.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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Manufacturer Narrative
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Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: bi31001255, lot/serial #: n/a h3) the battery was returned to the manufacture for evaluation.After performance testing and visual/physical examination the reported issue was confirmed.Battery failed bench test.During bench test, fluke digital multimeter was used to measure battery.Battery is measured at 1.632 vdc which is under the valued spec of 3 vdc.Battery no longer charge.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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Search Alerts/Recalls
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