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 visualization of particles in the air in the outlet port and the device is noisy.The patient reports their breathing is not smooth in the mid night and itchy nose.The patient further reports runny nose, cannot sleep well.The patient states cleaning the tubing every week and stopping use of the device after watching the news in 2023.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.
|