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 eye, nose and skin irritation, respiratory tract irritation.Also, dizziness and/or headache, hypersensitivity, nausea / vomiting, inflammatory response, kidney disease/toxicity, reduced cardiopulmonary reserve and hypertension, loss of balance.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.
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