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Model Number ACT100 |
Device Problems
Device Alarm System (1012); Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2023 |
Event Type
malfunction
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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 instrument was failing controls and showing error code 69.The procedure was aborted.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the problem was with the flag motor and/or the reagent motor, as indicated by error code 69.The service technician noted that the device would pass the electronic quality control(eqc) with a bad motor, but not the liquid controls.Quality controls are performed according to the facility¿s requirements and the schedule is unavailable.
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Manufacturer Narrative
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Device evaluation:the reported issue of failing controls and showing error code 69 was verified during service.The service technician checked the error log and found error code 69 again.The issue was resolved by replacing the flag and reagent motors.Preventive maintenance and wet normal and abnormal qcs as well as the electronic quality control (eqc) were performed per specifications.Note that the instrument was not returned to medtronic facility but was serviced by field service technician.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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Manufacturer Narrative
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Conclusion: after investigation at medtronic, the complaint is confirmed for the act plus instrument failing controls and showing error code 69.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.The act plus software constantly monitors for software and/or hardware faults.When one is found, an error is displayed and typically addressed by the operator.No further actions to be taken at this time.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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