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 is experiencing nasal/throat irritation or soreness and a runny nose while using the device.Patient also alleged visualization of particles in the tubing and chamber and the filters are dirty.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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