The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 02-mar-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the second of three reports.Refer to 3011270181-2020-00039 for the first event.Refer to 3011270181-2020-00041 for the third event.It was reported the heat and moisture exchanger attached to the end of the endotracheal tube (ett) and to the ventilator circuit disconnected during ventilation.There was no reported injury and the device was replaced.
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The device history record for the reported lot number, 2019-04-15, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One used sample device was received.No product packaging was received with sample device.The product did not contain a lot number identification.The was evaluated and the failure was confirmed.The root cause was manufacturer related.All information reasonably known as of 21-may-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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