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 patient alleges that he was diagnosed with stage 3 kidney disease.Patient states that he suffers from respiratory tract irritation, nose and eye irritation, headaches and abnormal heart rhythm due to the device.Patient also stated that he had to have his tonsils removed.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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