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 dry throat, headaches, nosebleed and feels suffocating.Also, the patient alleges that the device gets really hot and showing change filter message.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Despite of multiple attempts, mandatory questions were not answered.The device has been returned to the manufacturer, but evaluation has not yet begun.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.
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