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 has been experiencing sneezing due to what seems like the accumulation of dust while using the machine.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device was returned to a third-party service center 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 device was visually inspected and scrapped at the third-party service center during the device evaluation.No evidence of foam degradation was found, and neither were particles visible.
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