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 skin irritation, dizziness and/or headache, asthma (new or worsening), reduced cardiopulmonary reserve, other.There was report of serious or permanent harm or injury.Device has not been returned to the manufacture for 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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