Device evaluation summary: the reported smoke smell, over heating and display issue were verified during service.The service technician noted that the instrument had no display and they found u38 on the system controller board had burn marks.The service technician replaced the user interface (ui) pcba and system controller board.After operation checks the same result occurred of no display and damage to the board.The service technician replaced the bitsy xb for the ui and noticed that there was a faint display on this check.The issue was resolved by replacing the backlight power supply.Post-repair testing was performed per specifications.Conclusion: complaint confirmed for the reported smoke smell, over heating and display issue during service.There were no patient/clinical safety issues reported.Review of the complaint file indicates sufficient information was provided for completion of this investigation.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.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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Medtronic received information that prior to use, during set up of this bio-console base and user interface instrument the customer noticed a smoke smell coming from the instrument, they felt like it was overheating and it did not show a display.The instrument was changed out with a backup and there was no reported adverse patient effect.
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