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 issue related to a bipap device's sound abatement foam.Section b5 has been corrected and should be reported as: the manufacturer received information alleging visualization of particles, device is leaking, device overheating, device/power cord or supply too hot to touch related to a bipap 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 corrected (medical device problem codes) and updated in this report.
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