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Model Number ACT200 |
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 02/22/2022 |
Event Type
malfunction
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Event Description
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Medtronic received information that prior to use during set-up of this act plus instrument, it was reported that the instrument had a faulty reading and displayed an error message.Use of the instrument was unspecified and there was no resulting adverse patient effect.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device evaluation summary: the reported faulty reading and error message were verified during service.The service technician was unable to replicate reported fault.They checked the error logs and all seemed okay.During the preventive maintenance procedure, the service technician observed dried blood on the flag sensor and they noted that this was causing the incorrect readings.This issue was resolved by cleaning and sanitizing the instrument and cleaning the flag sensor.Preventive maintenance was performed as per specification.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: the complaint is confirmed for the act plus instrument¿s reported faulty reading and error message.The issue was verified during service.The technician was unable to replicate the reported fault.The service technician checked the error logs, and all seemed as expected.During the preventive maintenance procedure, the service technician observed dried blood on the flag sensor, and they noted that this was causing the incorrect readings.This issue was resolved by cleaning and sanitizing the instrument and cleaning the flag sensor.Preventive maintenance/testing was performed per specifications.No patient/clinical safety issues were reported.Trends for issues with this product are monitored.Correction b5: the instrument was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.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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