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, headaches, eye irritation and skin irritation related to a bipap device's sound abatement foam.There was no report of patient harm or injury.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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Placed a call to customer requesting device return, mandatory questions and additional information regarding reported health conditions and particles.Left message on voice mail.Heath effect codes are captured ( headaches, eye and skin irritation) in this fallow-up and section h6 updated in this report.
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