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Model Number 10049998 |
Device Problem
No Flow (2991)
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Patient Problems
Death (1802); Respiratory Failure (2484)
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Event Date 06/12/2020 |
Event Type
Death
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Manufacturer Narrative
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Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.Multiple attempts have been performed to obtain additional information but to date no further details have been provided.This report is being conservatively filed due to patient death with no additional details.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during use on an intubated patient, the 840 ventilator ¿turned off and he died¿.Multiple attempts have been performed to obtain additional information but to date no further details have been provided.This report is being conservatively filed due to patient death with no additional details.
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Manufacturer Narrative
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Device evaluation summary: the medtronic field service engineer(fse) evaluated the ventilator and noted that the equipment was "outside the electric network" on the date of the event in the ventilator memory.The fse preformed self tests and preventative maintenance on ventilator and found no failures with the ventilator.The ventilator is waiting for parts to be replaced as a part of preventative maintenance.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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Additional code added to section h6 patient codes.Corrections: section h6 evaluation code conclusion section g pma / 510k number h3 device evaluation summary: the service personnel (sp) inspected the ventilator and found alert "maximum message delay exceeds code: zc0070".It was disconnected by an operator.Last short self test (sst) test was performed on 10/02/2017.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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Search Alerts/Recalls
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