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 reported an allegation of an issue related to a bipap device's sound abatement foam.The manufacturer received information alleged blood clots.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's service center for further evaluation.The evidence of sound abatement foam degradation/breakdown was not observed in the base unit but the device was evaluated and slight dust/dirt contamination inconsistent with degraded sound abatement foam was abserved throughout device enclosure and airpath, suggesting a source external to the device.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.The manufacturer found 4 errors found (err_sensor_unreliable (1127179 v04)).The manufacturer concludes that they confirm the customer's allegation and there is dust / dirt contamination and the presence of contamination in the airpath, source of contaminations were external to the device.
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