The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging skin irritation other heart problems, high blood pressure, breathing problems, spots in lungs, and skin issues on the face.There was no report of medical intervention.No additional information can be requested at this time.This device has been returned and was remediated with new foam and a blower on 12/01/2021 and was returned to the same registered user on 2/02/2022.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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