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 lung cancer and kidney damage and broken humidifier water chamber related to a cpap device's sound abatement foam.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, an addendum to this follow-up report will be filed.Section b3 and g4 corrected and updated in this report.Section h6 updated in this report.
|