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 patient is alleging a-fib and lung disease.In addition, the patient also alleged chronic congestion/sinusitis symptoms, possible pleural effusion and nose irritation and respiratory tract irritation.At this time, no medical intervention has been reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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