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 atrial fibrilation, myocardial infarction, stroke, respiratory problems, and triple bypass 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 atrial fibrilation, myocardial infarction, stroke, respiratory problems, and triple bypass surgery related to a cpap device's sound abatement foam.The device may have caused or contributed to the reported event.The patient did not report to receive medical intervention.There is no customer information hence we cannot reach out to the customer 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.
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