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Model Number 560BCS1 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
malfunction
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Event Description
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Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the instrument shut down when the power input was off.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.Medtronic received additional information that it is unknown how long the battery has been installed in the instrument and the lot number of the battery that was removed from the instrument is unknown as there is no service record.
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Manufacturer Narrative
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Device evaluation summary: the reported issue of the instrument shutting down when the power input was off, was verified during service.The issue was resolved by replacing the battery.Preventive maintenance was performed per specifications.Note: the instrument was analyzed/serviced in the facility by a field service technician.The instrument did not return to a medtronic facility for service.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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Manufacturer Narrative
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Correction b5: medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the instrument shut down when the power input was off.The instrument was replaced.There was no patient involvement, so no adverse effect occurred medtronic received additional information that it is unknown how long the battery has been installed in the instrument and the lot number of the battery that was removed from the instrument is unknown as there is no service record.Correction c: imf code updated.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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