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 asthma (new or worsening) and reduced cardiopulmonary reserve.In addition, the patient also alleged eye irritation, nose irritation, skin irritation, respiratory tract irritation and nausea and vomiting.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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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.H3 other text : device has not returned to the manufacturer.
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