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Model Number 560BCS1 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported battery issue was verified during service.The service technician observed that the battery could not supply power.The issue was resolved by replacing the battery.Post-repair testing was 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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Event Description
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Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the battery was not powered and the inspection showed that the battery was damaged.The battery could not supply power.The instrument was not used.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that when the ac power switch was turned off, the instrument immediately shut down and the battery could not provide power.It was stated that the battery was installed in the instrument since july 17, 2020.The customer stated that there was no field corrective action (fca), just a repair.
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Search Alerts/Recalls
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