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 voluntary medwatch (mw5149782).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging a smell when i took of my cpap mask in the morning.I recently saw model is defective and emits a chemical.There was report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|