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 of nose irritation, dizziness and/or headache, nausea / vomiting, lung disease and respiratory tract irritation.The manufacturer was made aware of this complaint through a representative of the customer.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|