The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, and mechanical ventilator devices.The manufacturer received information alleging cough, horsness in voice, nasal/throat irritation or soreness, nose bleeds, runny nose, difficulty breathing/short of breath.There was no report of seriuos 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.
|