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 cpap device's sound abatement foam.The patient has alleged nasal/throat irritation and soreness, shortness of breath, dizziness, lightheadedness, headaches, cough, congesting, sinuses problems, stuffy nose and throat, extreme fatigue, voice is weaker, cannot talk/project voice.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer and found a blown chip on the pca and thermal damage to the top enclosure.Also found there was a dark stain on the bottom enclosure.The manufacturer found there was no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 0 errors.The device was applied power and the device operated properly.The manufacturer concludes contamination of dark stain contamination were external to the device.The manufacturer concludes there was no evidence of sound abatement foam degradation.
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