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 alleged waking up tired while on the machine feeling frustrated, coughing, sore throat, nasal issues.In addition, the patient states of trying nasal spray to help but still drying out and uses the pillars in her nostrils.There was no report of serious or permanent patient harm or injury.There was no report of medical intervention taken in regard to this event by the patient.The device was returned to a third-party service center.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
|