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 an issue related to a bipap autosv adv device's sound abatement foam.The patient has alleged device has strange odor, nasal/throat irritation or soreness, shortness of breath.There was no report of serious patient harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.Due to potential litigation surrounding this case, no follow up can be performed at this time.If any additional information is received, a follow up report will be filed.
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