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 states that received the replacement device but is still getting black residue and no water in the chamber.The patient alleges difficulty breathing and burning sensation.Medical intervention was not specified.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.
|