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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 05/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported issue with channel 2 when running quality controls (qc's) was verified during service.The service technician observed that the lift wire motor was not parking properly.The issue was resolved by replacing the sensor wire harness.The service technician then ran the parking test 20 times, and it parked in the same position every time.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 to a medtronic facility for analysis.Conclusion: after investigation the complaint is confirmed for the act plus instrument¿s issue with channel 2 when running quality control.No patient/clinical safety issues were 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.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 prior to use of an act plus instrument, it was reported that there was an issue with channel 2 when running quality controls (qc's).The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the acttrac was used and it passed, liquid control was also used and it failed.There were no error codes associated with the issue.Control values were not obtained.
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Manufacturer Narrative
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H.4.Instrument is older than 2015 so best estimate used.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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