Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Device evaluation summary: the reported issue that this bio-console instrument had an error 25 was not verified during service.The service technician found no errors in the log file, also no errors occurred when the instrument was being operated.The back-up batteries did not charge anymore and the instrument shut down within a few seconds when the power outlet has been disconnected.It was also observed that the charging circuit on the system controller did not charge correctly.The issues were resolved by cleaning the instrument and replacing the hw, screw, 8, ph, pl, ss, 1.0, the assy system controller module -006 and the battery ,12v,6.5 ah,certified.Preventive maintenance was performed per specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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