Device evaluation summary: the reported measurement issue was verified during service.Technician was unable to duplicate the issue however during service, observed instrument requires cleaning, tilt frame is cracked and upgrade is required before final testing.This issue was resolved by cleaning the measurement channels and replacing the tilt frame, keypad, keypad overlay, softkey switch and softkey overlay.Keypad plate was replaced.Software was updated from 2.0.1 to 2.0.2.Post repair testing was performed per specification.Conclusion: the complaint is confirmed for the act plus instruments measurement issue.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.The act plus white paper describes the most common failure modes and the clinical impact of these.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.
|