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.The manufacturer received information alleging that the patient has high blood pressure, difficulty breathing/short of breath, chest feels clogged up and headaches.There was no serious patient harm or injury.The patient required no medical intervention.Additional information received from the clinical expert's review of the complaint has determined that the reported event of high blood pressure, difficulty breathing/short of breath, chest feels clogged up and headaches were both deemed as non-serious, non-reportable injuries; however, the difficulty breathing/short of breath, chest feels clogged up and headaches are possibly related, and high blood pressure is not related to the product problem with the device and/or user error.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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