The manufacturer was contacted about 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 inhalation and digestion of foam degradation and increased risk of illness.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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The manufacturer previously reported information about 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 inhalation and digestion of foam degradation and increased risk of illness.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.In this report, the cfn/fei # was incorrectly selected.A new report has been filed with the correct cfn/fei #.The pr # is (b)(4).
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