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.Per the legal department, the patient has alleged respiratory tract irritation, asthma (new or worsening), lung disease, cancer, and a final allegation of "other." no other clinical information or medical intervention was specified.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 an updated report at this time.If pertinent information becomes available to the manufacturer later, an addendum to this follow-up report will be filed.
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