It was reported that the patient developed cyanosis, restlessness, and decreased heart rate after 24-hour use of the e360 ventilator.Additionally, it was reported that the ventilator did not alarm and ventilation stopped.The medical staff immediately disconnected the ventilator and provided manual ventilation via balloon to assist in breathing.The patient was not aspirated due to the event, but was placed on an alternate ventilator.
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Component code added.Additional information: medtronic conducted an investigation based upon all information received.The device was not available for evaluation.The product won't be sent back.This event was reported from the adverse reaction event center of shanghai, rather than reported directly to medtronic by the customer.The current status of the product was unknown and could not be returned.Device history review: the ventilator passed all production testing, there is no evidence of rework having been carried out on the ventilator.All test results were within the required specification.There is nothing in the manufacturing process seen that could have contributed to the reported event.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality 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.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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