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 and stroke.The patient also alleged other thermal issues with the device.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported information 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 and stroke.The patient also alleged other thermal issues with the device.Medical intervention was not specified.During a good faith effort attempt, the following additional information was provided: the patient has an underlying medical diagnosis of sleep apnea.The patient had a tia, which the doctor said was due to stress, and was hospitalized for a week.The timeline of the tia was not given.The patient stated they received medical intervention for the difficulty breathing, but specific medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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