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 visualization of particles related to a cpap device's sound abatement foam.The patient had alleged to have kidney failure.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.As customer's wife lifted the call and said her husband already received replacement and hung up the call declining to provide responses to the questions.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.
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