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 an issue related to a cpap device's sound abatement foam.The patient has alleged eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, nausea / vomiting, asthma (new or worsening), inflammatory response, reduced cardiopulmonary reserve.The manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.
|