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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 05/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported battery power failure issue was verified during service.Service technician observed one of the batteries was below the charge threshold and had a corroded terminal.The issue was resolved by replacing the battery.Preventive maintenance was performed as per specification.D9: instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use of a bio-console 560 instrument, it was reported that the unit was taken off ac power, but the battery could not keep it powered on, and the unit shuts off.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.
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Manufacturer Narrative
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Additional information b5: medtronic received additional information that the batteries had been installed for three years.The lot number for both batteries that were removed was 11626434.The instrument immediately turns off when the wall power was removed.The customer has not confirmed why battery power was required.After replacement, the battery indicator and alarms worked properly during testing.Correction device evaluation summary: the reported battery power failure issue was verified during service.The service technician observed that one of the batteries was below the charge threshold and had a corroded terminal.The issue was resolved by replacing the batteries.After the batteries were replaced the instrument was able to stay powered without needing to be plugged in.A performance check was then run to verify the instrument was in good condition.Preventive maintenance was performed as per specification.Correction h6.4 (eval code result (fdr/annex c): this code has been updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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