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 received information alleging headache, nausea, chronic sinus infection, and severe pain.Additionally, the patient alleges that the patient is under a doctor's care and the neurologist is sending him for an mri and the patient has been in contact with his pulmonologist.Patient also alleges that the patient in on pain medication.The patient reported using an ozone-based disinfection device.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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