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 headaches, earaches, vomiting, nausea, difficulty breathing/shortness of breath, fatigue, and tiredness because of extreme lack of oxygen.There was no report of patient serious harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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