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Model Number ACT200 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported sporadic failures in value reading were not verified during service.The service technician found no issues and they believe this might be due to mishandling by the user.The user was shown the procedure for use.Preventive maintenance was performed as per specification.Conclusion: the complaint was not confirmed for the act plus instruments sporadic failures in value reading.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.Instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center 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.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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Event Description
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Medtronic received information that during use of an act plus instrument, it was reported that the instrument had sporadic failures in value reading.The instrument was replaced to complete the procedure.There was no patient involvement, so no adverse event occurred.Medtronic received additional information that the reported issue is sporadic failure in value reading, there was no accepted value read.Medtronic received additional information that the instrument was taking measurements, but instrument was not used, as it was replaced.Quality control is performed on this instrument once per year as per procedure.Test results were not obtained, and heparin was not administered to patient, as there was no patient involvement and the instrument was replaced.Medtronic received additional information that this instrument was not used on a patient, but only used to get values outside a patient environment.The patient was not involved because the values were not obtained causing the customer to use another instrument.
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Manufacturer Narrative
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Correction b5: there was no adverse patient effect associated with this issue.Correction additional codes imf (annex f): this code has been updated.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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Search Alerts/Recalls
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