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 nose irritation and blotches on her face.There was no report of patient harm or injury.The device was returned to the manufacturer¿s product investigation laboratory for investigation.The device was visually inspected by the manufacturer found evidence of black contamination to the blower box, dust/dirt contamination on the blower inlet seal, and also keratin-like contamination to the blower box outlet and air inlet.There was evidence of sound abatement foam degradation.
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