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 manufacturer received information alleging that the patient has lightheadness, headache and difficulty breathing/short of breath.The patient has also alleged device will not turn on and device not functioning, while using the machine it had spark.There was no serious patient harm or injury.The patient required no medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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