The manufacturer received a voluntary medwatch (mw5151144) in reference to the field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging visit to doctor for chest checkup due to mucus cough, and the patient had also difficulty in breathing, pneumonia, sick, and on antibiotics.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|