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Model Number 9735602 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735602, serial/lot #: (b)(4).The computer was returned to the manufacturer for analysis.The returned computer has an intermittent jittery display.The display anomaly started a minute or two after power up.The hardware investigation found that the reported event was related to a hardware issue.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 used outside of a procedure.It was reported that while loading exams for next week's procedures, the monitor display began jumping back and forth.At that point the system was in a storage room, and the attached video was taken there.The site reboot the system twice with no change.Then shut it down and moved outlets, with no resolution.After that they shut the system down and moved it to an or and boot it up, again with no change.There was no patient involvement.
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Manufacturer Narrative
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H2) correction: h3 corrected.H3) a medtronic representative went to the site to test the equipment.Testing revealed that the video signal on the computer has poor quality.The image jumpe daround the screen consistently.The aio computer was replaced, the system then passed the system checkout and was found to be fully functional.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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