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 a voluntary medwatch (mw-5112625) in which it was alleged that the patient was experiencing difficulty breathing, pain, sweating, fever, weak, burning in the throat and nose and pneumonia while using the device.Medical intervention was prescription antibiotics.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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