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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 02/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the reported battery faults issue was verified during service.During preliminary analysis the service technician found error codes displayed 43,69, and 71 after power on.Service technician found the mpuboard and battery were broken.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 there were battery faults.There was no interruption in use and the instrument could be run normally.There was no adverse patient effect associated with this event.
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Manufacturer Narrative
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Medtronic received additional information that it was known the battery had a defect during usual inspections.The battery power lasted 0 minutes.The displayed battery charge indicator and battery alarms did not alarm.The battery was required for transit.A hand crank was not required.The battery had been installed in the instrument for about 5 years.The lot number of the battery removed from the instrument is unknown.The issue will be resolved by replacing the assy system controller module-006 (pn.M021374c001).Preventive maintenance will be 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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Manufacturer Narrative
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Additional information for the device evaluation summary: the reported battery faults issue was verified during service.During preliminary analysis the service technician found error codes display 43, 69, and 71 after power on.The service technician found the mpu board and battery were broken.The service technician cleaned the dust from inside the instrument.The issue could be resolved by replacing the assy system controller module 006.The service technician stated that the instrument could not be repaired, as the customer rejected the quote, and it was returned to the customer.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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