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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 04/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported incorrect values issue was verified during service.The service technician observed that the flag sensor was too dirty.The issue was resolved by replacing the lift drive assembly and sensor.The service technician also completed cleaning of the instrument.Preventative maintenance was performed per specifications.Note: the instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return to a medtronic facility for service/analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that at an unspecified time, this act plus instrument was providing incorrect values.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.
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Manufacturer Narrative
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Correction b5: medtronic received information that prior to use of a act plus instrument, it was reported that the instrument was providing incorrect values.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Additional info b5: medtronic received additional information that acttrac controls were used and the quality control is performed once a year for the instrument.There was no error code and no control values were obtained.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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