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Model Number ACT100 |
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 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported issue that the instrument did not count correctly was verified during service.Visual inspection was performed, general cleaning of equipment, no fluids were found, only dirt.Internal cleaning of optics and alignment of the agitation bar was performed.Heating block temperature verification, three-way verification agitation time levels using the electronic control (active track) was performed.An addendum verification list was run, equipment remained operating under the manufacturer¿s parameters.Preventative maintenance was performed per specifications.Conclusion: after investigation at medtronic, the complaint is confirmed for the act plus instrument not counting correctly.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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Event Description
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Medtronic received information that at an unspecified time, this act plus instrument did not count correctly.The use of the instrument was unknown.There was no patient impact reported with this event.
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Manufacturer Narrative
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B.5 updated-medtronic received information that during use of an act plus instrument, it was reported that the instrument did not count correctly.The instrument was used to complete the procedure.There was no patient impact reported with this event.Medtronic received additional information that the instrument did not count during the test.It was not specified whether liquid or electronic (acttrac or heptrac) controls were used.Preventive maintenance is carried out every six months on the instrument.There was no error code associated with this issue observed.Correction to b.3 event date and g.3 aware date to 14 july 2023.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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