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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 07/05/2022 |
Event Type
malfunction
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Event Description
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During preventive maintenance by a service technician this bio-console instrument had internal batteries that did not reach the max level of charge in the expected time. this was detected during service so there was no patient involvement, so no adverse effect occurred.
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Manufacturer Narrative
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Device evaluation summary: during preventive maintenance by service technician the internal batteries did not reach the max level of charge in the expected time.The issue was resolved by replacing the batteries and the cover magnet.Preventive maintenance was completed per specifications.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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Manufacturer Narrative
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Correction h10: the cover magnet which was mentioned as part of the bio-console base in the device evaluation summary that was submitted in the initial mdr is not part of the bio-console base.Corrected device evaluation summary: during preventive maintenance by service technician the internal batteries did not reach the max level of charge in the expected time.The issue was resolved by replacing the batteries x2.Preventive maintenance was completed per specifications.Additional information: conclusion: complaint confirmed for the internal batteries did not reach the max level of charge in the expected time.This occurrence was identified during preventive maintenance, therefore, there was no patient involvement.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.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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