The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused a mass in the lung, sinus and respiratory infections, cough, dizziness and chest pain.The patient has alleged to seeing particles in the airway.The patient did report to receive medical intervention and had the mass removed from the lung.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 became degraded and caused a mass in the lung, sinus and respiratory infections, cough, dizziness and chest pain.The patient has alleged to seeing particles in the airway.The patient did report to receive medical intervention and had the mass removed from the lung. 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 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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