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.Additional information was received that the patient is also alleging asthma and copd while using the device.The patient also has an underlying health condition of sleep apnea.Medical intervention was prescription breathing medication, daily inhaler, and rescue inhaler.Please see sections b7 and h6 for this updated information.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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