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 alleged nasal/throat irritation or soreness.In addition, device humidifier was not providing vapor.There was no report of serious or permanent patient harm or injury.The device was returned and the manufacturer not confirmed customer complaint, found no evidence of foam degradation during device evaluation.The device passed all final test.
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