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Model Number 560BC |
Device Problems
Device Alarm System (1012); Increase in Pressure (1491); Material Deformation (2976); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2023 |
Event Type
malfunction
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Event Description
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During preventive maintenance by a service technician of this bio-console instrument ,there was a ticking sound from the power supply after powering 'on' and the screen kept blank of the base unit and user interface.The dc output of the power supply dropped down (to ± 22v) and was out of specification.The service technician observed a broken female blind connector inside the base unit and errors 9 and 32 occurred in error log file.The back-up batteries were overdue and there was pressure leakage in channel 1 and 2.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:during preventive maintenance by service technician there was a ticking sound from the power supply after powering 'on' and the screen kept blank of the base unit and user interface.The dc output of the power supply dropped down (to ± 22v) and was out of specification.The service technician observed a broken female blind connector inside the base unit and errors 9 and 32 occurred in the error log file.The back-up batteries were overdue and there was a pressure leakage in channel 1 and 2.The issue was resolved by replacing the calibration seal,pcb assy,power supply,assembly 560 and 2 x back up batteries.The service technician also adjusted power supply to 30v and cleared error log.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.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 device evaluation summary: the issue was resolved by replacing the calibration seal, pcb assy blind connector, power supply, assembly 560 bio-console mp module and the backup batteries.Correction h6.3 (eval code result (fdr/annex c): this code has been updated.Conclusion: the reported event was confirmed.During preventive maintenance by a service technician on this bio-console instrument, there was a ticking sound from the power supply after powering 'on' and the screens on the base unit and user interface stayed blank.The dc output of the power supply dropped down to ± 22v and it was out of specification.The service technician observed a broken female blind connector inside the base unit and errors 9 and 32 occurred in error log file.The back-up batteries were overdue and there was pressure leakage in channel 1 and 2.This was detected during service so there was no patient involvement, so no adverse effect occurred.The issue was resolved by replacing the calibration seal, pcb assy blind connector, power supply, assembly 560 bio-console mp module and the backup batteries.The service technician also adjusted the power supply to 30v and cleared the error log.Preventive maintenance was completed per specifications.The batteries are expected to perform for up to 3 years from the date of battery manufacture.A review of complaint and service records associated with this unit found no other instances of battery replacement within 3 years.The batteries met their life cycle requirements.Due to the available information and the age of the instrument the most likely cause is normal component wear out.All associated risks are low, and no device related patient/clinical safety issues were 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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