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 rash on skin and face.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 no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 5 errors.Manufacturer concludes there was no evidence of sound abatement foam degradation.
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