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 remstar pro c-flex+ device's sound abatement foam.The patient has alleged to chapped lips, mouth sores, and device is not turning on correctly, the lid on the water tank will not close properly, and air is coming out where it is not supposed to.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|