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 that the patient had a heart attack and a triple heart bypass while using the device.There is no allegation of serious or permanent harm or injury.The patient required a triple heart bypass.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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