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 received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged device will not turn on/device not functioning.There was no report of serious or permanent patient harm or injury.The device was returned to a third-party service center.Evaluation result stated that the complaint was confirmed, and the technician confirmed particles in the air path during the device evaluation. there were some secondary findings.The device was scrapped.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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