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 difficulty breathing/shortness of breath while using the device.The patient states, the air pressure went on strong by itself from normal setting 10.Reported at 10 was blowing much higher than 10 like at a 20.It was hard to breath, couldn't breathe out in anyway.Medical intervention was not specified.Three attempts were made to gather additional information.The device was returned to the manufacturer 01/11/2023 and is pending the outcome of the device eval/investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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