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 pain, difficulty breathing and stage 4 mediastinal cancer.The patient states the cancer was "established on (b)(6) 2023 , while i was followed by a pneumologist and ct scan until (b)(6) 2022 ", with no symptoms detected until use of the device.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed, and the manufacturer is submitting a final report at this time.If any pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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