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 nose irritation, respiratory tract irritation, dizziness, headache, hypersensitivity, asthma (new or worsening), inflammatory response, kidney disease/toxicity, lung disease, reduced cardiopulmonary reserve, and cancer.Medical intervention was not specified.The patient additionally reported the device stopped working and will not turn on.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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