Device evaluation summary: the reported communication issue with the base was not verified during service.The user interface (ui) was tested with the base unit and no issues were observed.The reported the dial on the ui was moving at random, it was not fixed and the ui was not fixed were verified during service.The service technician noted that the upper link was loose from the housing, the pin was broken, the lower link pin was bent and the rpm pot wiper resistance was unstable.During service the technician noted that the touch screen was cracked.The issues were resolved by replacing the bolt rib neck 1.0"x 0.274", pin spring ø3/16 0.875 zinc ps, cable assy internal ui 560, kit bio-console ui gasket, assembly swivel and link ui.Preventive maintenance was performed per specifications.Conclusion: complaint not confirmed for the reported communication issue with the base during service.There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.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 (b)(4) 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.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 during pre-op, during use of a bio-console base, user interface (ui), external motor drive and flow transducer an error message appeared on the user interface which stated communication to base unit lost, the customer noted that the flow transducer was broken, the dial on the ui was moving at random, it was not fixed and the ui was not fixed.The instrument was changed out with a backup and there was no resulting adverse patient effect.
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