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Model Number 560BCS1 |
Device Problems
Device Alarm System (1012); Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Event Description
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Medtronic received information that prior to use of a bio-console instrument, it was reported that the main pcb is defective.Use of the instrument was unknown. there was no patient involvement, so no adverse effect occurred.Medtronic received additional information stating that the part number of the pcb board was m021374c001.There was no smoke observed.The customer stated "it should power on first then display error code".Medtronic received additional information clarified that the instrument displays error code 43 after power on, and that there is no issue with the power.
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Manufacturer Narrative
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Preliminary analysis by service technician verified the printed circuit board is defective.Technician observed the fault is related to the printed circuit board.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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Product analysis: the reported issue of the printed circuit board being defective was verified during service.The issue was resolved by replacing the assy 560 bio-console syscon.Post repair testing was completed per specifications.Conclusion: the complaint was confirmed for the reported issue of the printed circuit board being defective.The issue was resolved by replacing the assy 560 bio-console syscon with a new version of the part.Post repair testing was completed per specifications.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.Trends for issues with this instrument are reviewed at quarterly quality meetings.Correction h8 (usage of device): this field was updated to reuse.Correction d8 (was dev serviced by third party?): this field has been updated to no.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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