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 nose irritation, respiratory tract irritation, dizziness and/or headache, inflammatory response, and lung disease.The manufacturer was made aware of this complaint through a representative of the customer.Medical intervention was not specified.The device was returned to a third-party service center for investigation.The third-party service center found the unit without any contamination and "the unit has good quality, no reject[ions]." there were findings of a reboot error related to the circuit board.The sound abatement foam was replaced as a preventative measure.The device was returned to the customer for use.
|