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 nose irritation and red spots.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 visual inspection was completed by the manufacturer.The manufacturer found evidence of small amount of dirt/dust contamination in the fresh air intake port of the device.An internal visual inspection was completed by the manufacturer.The manufacturer found evidence of dirt/dust in the blower motor.The manufacturer found no evidence of sound abatement foam degradation.The manufacturer confirmed that the humidifier heater plate heats using a pil humidifier (sn (b)(4)).The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminates found were consistent with dirt/dust contamination in the fresh air intake port of the device, dirt/dust in the blower motor.The manufacturer confirmed there was no evidence of sound abatement foam degradation.
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