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 bipap device's sound abatement foam became degraded and caused a patient to develop kidney disease, cough, headache and shortness of breath.These events were assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.Section b5 has been corrected and should be reported as: the manufacturer previously received information alleging an issue related to a bipap device's sound abatement foam became degraded and caused a patient to develop kidney disease, cough, headache and shortness of breath.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 corrected (added 1880, 1816 and 4457) and updated in this report.
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