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 an issue related to a dreamstation expert device's sound abatement foam.The patient has alleged asthma, headache, nasal and sinus congestions, acute chest pain.There was no medical intervention required by the patient.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|