The manufacturer received information alleging an issue related to a bi-pap device's sound abatement foam.The patient alleged having hospitalization due to lung infection, difficulty breathing/short of breath, also alleged heart issue.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 patient was hospitalization due to lung infection, difficulty breathing/short of breath, also alleged heart issue related to a bipap device's sound abatement foam.The patient did not report to receive medical intervention.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.The manufacturer is submitting a 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 was updated in this report.
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