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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 Type
malfunction
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Manufacturer Narrative
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Note:instrument returned but not yet analysed 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 during use, this act plus instrument had a measurement malfunction.The instrument was replaced.There was no adverse patient effect reported with this event.Medtronic received additional information that two measurement numbers appeared, but there was a large discrepancy between both numbers, and it did not improve even after trying several times.Neither liquid nor electronic (acttrac or heptrac) controls were used.There was no error code associated with this issue observed.The value was obtained, but the discrepancy between the two values was large.A test was conducted, but heparin was not administered because the discrepancy between the two values was large.The instrument is regularly maintained by cleaning after use.
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Manufacturer Narrative
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Device evaluation summary: the reported measurement malfunction was not verified during service.There was no reproducibility of the issue.The instrument will be disassembled, cleaned and adjusted as a precaution.Preventative maintenance will be performed per specifications.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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