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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 04/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 prior to use of an act plus instrument, it was reported that the liquid hr-nm and hr-ab are resulting with "insufficient data" errors; no result for channel 2.The count down (pre-warming) displays on both channels.But once the lift wire engages, channel 2 does not display any numbers (seconds).Channel 1 displays the numbers (seconds) as usual. at this point the acttrac 98 and 190 are passing. this is a continued issue, and have been serviced twice in the field.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.
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Search Alerts/Recalls
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