The manufacturer previously reported an allegation of an issue related to sound abatement foam. a correction to b5 was made and should be reported as: 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 an issue related to a cpap device's sound abatement foam.The patient alleged to develop seizures and a cough.There is no report of the medical intervention that the patient has received at this time.The device was returned to the product investigation laboratory for further evaluation. the device was evaluated.The internal and external aspect of the device was inspected.The device powered on and airflow was confirmed.There were no errors found.During the investigation, the manufacturer observed an unknown contaminant on the sd module flip doors, top enclosure, on the iso port of the rear panel, bottom enclosure, and inside the air inlet of the blower box.An unknown dust contaminant was observed on the front panel.An unknown contaminant was observed on the o-ring of the rear panel and the rear panel.An unknown dust contaminant was observed on the bottom enclosure.An unknown contaminant consistent with mineral deposits and liquid ingress was observed on the blower cap, blower, blower seal, and blower box.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.
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