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 visualization of particles in humidifier and experiencing dizziness, burning in nose and chest, breathing issues, patient hears more "rattling, like a wheeze or crackling sound" when he is breathing, headaches, severe dizziness and nausea.Customer also alleged difficulty speaking and felt like his voice has been strained, inflammation issues, vomiting, and body aches.Patient explained these symptoms to his pulmonologist who thought it the burning could be caused by acid reflux.Pulmonologist prescribed a nasal spray.Device has not yet returned for the evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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