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 visualization of particles and eye burn 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, customer did not return the device.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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