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.Description-the device stopped working and he acquired infections-he did not stop using the device: the patient has alleged to stomach and hip infection.The patient stated the machine stopped working and he needs to use his machine.The patient alleges the device has caused him to have stomach and hip infections and then required 4 surgeries to remove these infections.Medical intervention of surgeries was reported.Device has not been returned to the manufacture for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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