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 alleges difficulty breathing/short of breath and sleeplessness.Patient also states that the device causes him to feel a "drowning sensation" and also wakes him up.There is no allegation of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.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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