The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged can't breath, his eyes are red every morning and feels raw, he had 4 heart attacks and had open heart surgery.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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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 an issue related to a cpap device's sound abatement foam.The patient alleged can't breath, his eyes are red every morning and feels raw, he had four heart attacks and had open heart surgery.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 an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 has been updated in this report.
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