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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.The device was returned to third party service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.There was damaged buttons on upper enclosure, scratched ui panel and missing anti-slip rubbers in bottom enclosure.The internal aspect of the device was evaluated and there was no mention of visual findings but pcba electrical damage observed.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 there was no visible foam degradation.Unit scrapped.Section h6 updated in this report.
|