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Model Number 560BCS1 |
Device Problems
Display or Visual Feedback Problem (1184); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Medtronic received information that during use, when booting the bio-console 560 instrument, it was reported that there was a burnt smell, smoke and a black screen.Use of the instrument was unknown.There were no adverse patient effects because of this issue.Medtronic received additional information stating that information on whether the hand crank was required to maintain flow was not provided.The bio-console was intended to be used for an extra-corporeal membrane oxygenation (ecmo) case.
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Manufacturer Narrative
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Device evaluation summary: the reported burnt smell, smoke and a black screen was verified during service.The service technician found smoking after power on, the u38 on main printed circuit board burned out.The service technician found device home screen black.To resolve the issue, sub-assy ui 560 bioconsole, assy 560ui bitsy xb 2u02011 led display, pcba 560 display backlight pwm were replaced.The service technician found security board alarm.To resolve the issue, assembly, safety module, 560 was replaced.Additionally, system controller board, (previous part number: m014196c001 with a new version of the part (new part number m021374c001), replaced per (b)(4).There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.This occurrence is the result of the replacement of a component used in part number m014196c001.Additional investigation information, corrective and preventative actions will be documented in the medtronic corrective and preventative action plan (capa 518802).Trends for issues with this product are reviewed at quarterly quality meetings.Additional information b.5.Medtronic received additional information stating that the part number of the pcb board at the time this event occurred was m014196c001.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 h6.4 eval code conclusion/fdc/annex d: this field has been updated to d01.Correction h8 usage of device: this field has been updated to reuse.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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