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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the second attempt to have the device and components returned for evaluation, the customer stated that the device will be returned but the manufacturer has not received the device yet.The manufacturer received additional information, the customer alleged lack of air pressure.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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