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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 03/17/2022 |
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 prior to use of a bio-console 560 instrument, it was reported that there was a burnt smell, smoke and a black screen when booting.Use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information stating that the issue was observed prior to the instrument being used on a patient and as a result the hand crank was not required to maintain flow.The issue happened when the bio-console was turned on the first time for this clinical case.The event did not occur during a powering cycling of the bio-console.There was no fluid running through the pump when the event occurred.The bio-console was not being used by the patient during a clinical procedure when the issue occurred.
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Manufacturer Narrative
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Product analysis: the reported burnt smell, smoke, and a black screen when booting was verified during service.The issue was resolved by replacing the assy 560ui bitsy xb (b)(6) led display and pcba 560 display back light pwm.Additionally, the system controller board was removed, and a new version was installed.The instrument passed all testing.Post-repair testing was performed per specifications.Conclusion: the complaint was confirmed for the reported burnt smell, smoke and a black screen when booting during service.There were no patient/clinical safety issues reported.This occurrence is the result of the replacement of a component used in the system controller board.Trends for issues with this instrument are monitored.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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