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 cpap device's sound abatement foam.The patient has alleged nose irritation and respiratory tract irritation.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.
|