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 patient alleges headache and stomachache.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.A device was returned to philips service center and investigation is ongoing.Three attempts to gather additional information were unsuccessful.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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