Device evaluation summary: the reported light path failure issue was verified during service.The service technician was unable to duplicate the issue, but they found errors to support the light path failure.As a precaution the flag sensor pcb was replaced to resolve the light path failure issue.The reported quality control failure was not verified during service.Preventive maintenance was performed as per specification.Note: the instrument was analyzed in the facility by a field service technician.The instrument did not return a medtronic facility for analysis or service.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.
|
Medtronic received information that prior to use of an act plus instrument, it was reported that the instrument had an error for light path failure and it was also failing quality controls.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that both the electronic and liquid quality control failed.It was stated that the lot number of the liquid controls is unknown.
|