The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused hearing loss, tingling in fingers and toes, scabs and burning sensation in the nose, numb lips, eye irritation and headaches.The patient did not report to receive medical intervention.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 a cpap device's sound abatement foam became degraded and caused hearing loss, tingling in fingers and toes, scabs and burning sensation in the nose, numb lips, eye irritation and headaches.The patient did not report to receive medical intervention.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 updated in this report.
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