Device evaluation: the reported issue with wrong readings and measurements only in one cell was not verified during service.There w ere no errors found in statistic log file.The instrument did not work since the last maintenance.The issue was resolved by cleaning the instrument.The service technician explained to the customer the importance of the cleaning process.Preventive maintenance was performed per specifications.Note: the instrument was serviced by a field service technician within the facility.The instrument did not return to a medtronic facility for service.Conclusion: after investigation, the complaint is not confirmed for the act plus instruments wrong readings.The issue was not verified during service because there were no errors found in statistic log file.The instrument did not work since the last maintenance.The issue was resolved by cleaning the instrument and the service technician explained to the customer the importance of the cleaning process.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.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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Medtronic received information that prior to use, this act plus instrument provided wrong readings and it had measurements only in one cell.A back-up instrument was used for the procedure after the wrong measurement issue was observed there was no patient involvement, so no adverse effect occurred.Additional information received that the customer had not used the instrument since the last service.There were no wrong measurements observed with the acttrac.
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