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 a voluntary medwatch (mw5102810) alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop blood clots in their kidneys the patient was prescribed medication in response to the reported event.This event is assessed as not related to the device in this case.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.Sections d1, d2, d4, g4 and h4 has been corrected / updated in this report.
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