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 the patient to have severe anxiety,wheezy and also patient was not feel well and congested related to a cpap device's sound abatement foam.No medical intervention was mentioned for the reported event.The device has not been returned to the manufacturer 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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