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 dizziness, lightheadedness, and vertigo.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 external and internal visual inspection of device were completed by the manufacturer and found evidence of dark keratin particles on the blower box outlet port.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminate found was consistent with dark keratin particles on the blower box outlet port.The manufacturer confirmed there was no evidence of sound abatement foam degradation.
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