The manufacturer previously received information alleging an issue related to the device's sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.In initial reports section b5 mentioned incomplete, correct b5 should be: 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 previously received information alleging multiple acute pulmonary embolisms, constant pulmonary embolisms, asthma, fluid in lungs, thyroidectomy, abscess in trachea that blocked airway, and black particles in mask, tubing, and filter.Medical intervention of thyroidectomy and emergency medical intervention for a blocked airway was reported.The device was returned to the manufacturer's product investigation laboratory for further investigation.The device was evaluated, and the evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer observed the dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device.Evidence of water ingress on the blower and blower box was found.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and that there was no evidence of sound abatement foam degradation or breakdown observed in the base unit.The manufacturer confirmed the presence of contamination in the airpath.Section d8, d9, h2, h3 were updated in this report.Section h6 health effect - clinical code, type of investigation, investigation findings, and investigation conclusions have been updated.In section d4 unique identifier (udi) number has been corrected / updated.
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