The manufacturer received information alleging patient wake up and cannot breathe, heart racing, blood pressure raising and gasping for air states, morbid obese, related to a cpap device's sound abatement foam.There was no report of patient harm or injury.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 wake up and cannot breathe, heart racing, blood pressure raising and gasping for air states, morbit obess, related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the second attempt to have the device and components returned for evaluation, the customer refused to provide answers.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 updated in this report.
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