It was reported that while suctioning a patient that was connected to this 980 ventilator, the touchscreen was pressed, an audible sound was expected however, no sound was heard.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
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Correction to section h6 evaluation code method, result and conclusion codes.H3 device evaluation summary: it was reported that while suctioning a patient that was connected to this 980 ventilator, the touchscreen was pressed, an audible sound was expected however, no sound was heard.The service personnel (sp) inspected the ventilator and could not confirm the reported issue.A review of the ventilator logs showed unit had ui communication errors.The sp updated software.The ventilator passed all tests and calibrations per manufacturer specifications at the time of service.The investigation found the device to function normally as expected.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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