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Model Number 9735602 |
Device Problems
Environmental Compatibility Problem (2929); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 9735416.No parts have been received by the manufacturer for evaluation.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 a navigation system being used outside of a procedure.It was reported that while patient data was being imported, the system suddenly shut down.It was rebooted, but did not start up again.It was noted this occurred before and the computer was replaced.There was no patient involvement.Additional information was received.It was reported that the system was plugged in to a functional outlet when the issue occurred.It was also reported that when the startup malfunction occurred, the monitor was powered on; the computer's fan was turned on and off, and it was determined that there were no problems with the power supply.After the computer was replaced, the system worked properly.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Hardware parts were replaced.The system was then performing as intended.Codes b01, c13 and d02 apply to this system checkout.The computer was returned to the manufacturer for analysis.Analysis determined that the reported complaint was confirmed.The bios was set to (b)(6) 2007.It had a dead cmos battery.The installed programs started and ran normally.Codes b01, c13 and d02 apply to this analysis.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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