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 continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have fluid in lung.The patient was reportedly hospitalized in response to the event.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.Therefore, the device did not cause or contribute to a serious injury or death.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.Section b2 has been corrected / updated in this report.
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