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 an issue related to a cpap device's sound abatement foam.The patient has alleged of having headaches and swollen glands.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of the device was completed by the manufacturer and found evidence of an unknown white, gray and black contamination (dust-like) at the air input of the blower box.The manufacturer found evidence of short unknown gray hairs or fibers, gray contamination, light dust-like contamination and black contamination, consistent with keratin in the air input of the blower box, top of the filter, top of the blower motor, blower motor seal and the air outlet of the blower box.The manufacturer also found evidence of tiny unknown black and white specs of contamination on the bottom the blower box.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The device's event log was reviewed by the manufacturer and found no errors logged.The manufacturer concludes the contaminates found were consistent with- an unknown particulate, dust or dirt contaminates, fiber contaminates, and keratin, contamination inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.
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