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 previosuly received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop kidney tumors.The patient required surgery in response to the reported event.The patient also alleged to have sinus infections, eye issues and nasal/throat irritation or soreness.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 g4 had incorrect information which is updated in this report.Section h6 updated in this report.
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