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 bipap st30 device's sound abatement foam.The patient has alleged nose irritation, respiratory tract irritation, and inflammatory response.There was no report of serious patient harm or injury.No medical intervention was specified by the patient.The device has not yet 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.
|