The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 13-nov-2019 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).
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Avanos medical, inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the second of four reports.Refer to 3011270181-2019-00062 for the first event.Refer to 3011270181-2019-00064 for the third event.Refer to 3011270181-2019-00065 for the fourth event.It was reported the heat moisture exchange (mhe) was not fitting on the circuit with a tight fit.Additional information received 22-nov-2019 stated the event usually occurs between 2-hours and 6-hours during use.The vent alarm sounds when this occurs.The hme connection is simply reconnected to closed suction system (css) or changed out.
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The device history record for the reported lot number in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 06-mar-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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