MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Display or Visual Feedback Problem (1184); 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 06/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 the system would not boot up after installing software, the representative installed 1.3.2, shut down the system, upon boot up the medtronic further together appeared, the black screen, then blinking cursor.They swapped outlets and the issue did not resolve.They swapped outlets to a different room, and the screen booted into sql error mode and cursor in middle of the screen, would not boot.There was no patent present.
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Manufacturer Narrative
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H3, h6: a medtronic representative went to the site to test the equipment.Hardware parts were replaced.A system checkout was performed and the system was working as intended.The computer 9736242 aio flex ent eu-sc (007-2390246) was returned for analysis.Analysis confirmed the complaint.The computer briefly showed "ubuntu 18.04.2 lts stealthstation tty1 stealthstation login:" and then went to a black screen.A known good ssd was installed and the computer functioned normally without failure.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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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