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, skin irritation, respiratory tract irritation, dizziness, headache, hypersensitivity, nausea, vomiting, asthma (new or worsening), inflammatory response, lung disease, and reduced cardiopulmonary reserve.Medical intervention was not specified.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.The device serial number provided in the complaint details was (b)(6) (which did not match any device in our database).H3 other text : device not returned to manufacturer.
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