According to the reporter, the units were generating a 'ssssst" sound when it's being used.The customer reported that the patient had difficulty breathing when using the device.It was also reported that the patient could breathe daily with 4 liters oxygen support in speaking valve.It was also reported that the tube was cuffed, fenestrated and deflated, each speaking valve was immediately removed as it was observed after a few minutes that device did not work normally.
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Additional information: concomitant medical products, pma/510k, device evaluated by mfr: evaluation summary: one sample was received for evaluation.A visual inspection was performed and no cuts, deformities or damage was observed in the mem brane nor the diaphragm, the membrane is in the right position.No failure mode was observed in the received sample since met with the product specifications and no corrective actions are required.Information has been added to the database and trends will continue to be monitored.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.
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