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 getting black particles in machine related to a bipap device's sound abatement foam.There was no report of patient harm or injury.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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.In initial reports section b5 mentioned incomplete, correct b5 should be - the patient alleged getting black particles in machine related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Section h6 updated in this report.
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