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 that the device is not working, pressure fluctuation, patient has a trouble breathing as if he was not getting enough air, stop randomly, blowing inconsistent amount of air.There was no patients harm or injury.There was no medical intervention reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
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