Section b5 has been corrected and should be reported as: 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 cpap device's sound abatement foam.Patient is experiencing headache,shortness of breath, fatigue,lightheaded,high blood pressure due inhaling particles in tubing/chamber.There was no report of serious patient harm or injury.After third attempt to have the device and components returned for evaluation and investigation customer declined to respond to the gfe related questions and terminated the call.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final follow up report will be filed. section h6 updated in this report.
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