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 patient has alleged to woke up she felt hurt on her chest, she felt stomach pain and she felt hurt on her throat because of the pressure settings.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.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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