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Model Number 9735669 |
Device Problems
Display or Visual Feedback Problem (1184); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735825, serial/lot #: unknown, ubd: unknown, udi#: unknown.An update was provided from the field that after all the cables were disconnected from the computer besides the monitor, the issue was still occurring.All components were disconnected from the uninterruptible power supply (ups) besides the computer, power switch, and monitor power.The issue was still occurring.They got a hdmi to dvi cable and tried connecting that from the computer to the monitor and it still got no video.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.It was reported that while on-site replacing the computer and hard drive for a different case, it was found that after getting a passing registration, the system would go to "no video signal".During troubleshooting, after confirming all the cables were seated into the monitor, hard drive, and uninterruptible power supply (ups), technical services (ts) recommended deleting the demo exam (resin head).When acquiring the demo exam from the file system, the system went back to "no video signal".Ts recommended unplugging all instruments from the em and rebooting the system.After rebooting, ts recommended going to the registration screen.Ts then recommended plugging in the instruments into different ports than they were previously plugged in one instrument at a time and waiting 30 seconds in between.It was found that the instrument tracker was causing the system to boot into the "no video detected screen".There was no patient present when this issue was identified.An update was provided that issue was still occurring when the emitter and interface box were disconnected.Because the system was going to no signal after the instruments being plugged into the electromagnetic localization system box, it was suspected that there was a short in the component.After placing different instrumentation into the different ports, the em was very intermittent and would work on and off.
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Manufacturer Narrative
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D11 correction) section d information references the main component of the system and other applicable components are: product id: 9735786, serial/lot #: (b)(6).H6) a medtronic representative went to the site to test the equipment.All cables were disconnected from the replacement computer from the different case and the issue was still occurring.The issue was still occurring after disconnecting all components from the uninterruptible power supply (ups) besides the computer, power switch, and monitor power.The monitor still got the no video issue when trying to connect an hdmi to dvi cable from the computer to the monitor.The original computer was tested with the new hard drive and the system then functioned as intended.The new hard drive was kept and the replacement computer was replaced with the old computer.The system then passed a system checkout.The replacement computer was returned and analyzed in the different case and the malfunction was confirmed.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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