The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 14dec2021 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 (b)(4).
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Avanos medical inc.Received a single report that referenced 2 (two) different incidences, which were associated with separate units, involving 2 (two) different patients.This is the first of two reports.Refer to 9611594-2021-00186 for the second report.The customer reported that the cuff on the microcuff deflated.There was no reported injury and additional information has been requested.
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