The manufacturer previously reported an allegation of an issue related to sound abatement foam.There was no report of serious patient harm or injury.In initial reports section b5 mentioned incomplete, correct b5 should be: 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 headache, deep chest cough, sore throat, fever, pneumonia related to a cpap device's sound abatement foam.There was no report of serious 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 updated in this report.Section h6 (clinical code) corrected in this report.
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