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.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.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.Section h6 health clinical code has been corrected and type of investigation, investigation findings and investigation conclusions have been updated in this report.
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