The manufacturer previously reported a patient allegedly became disconnected from the bipap a40 device.The patient was in cardiac arrest and was transported to the hospital where the patient later died.The device was returned to the manufacturer for evaluation.The device was found to operate and alarm to design specifications.It was reported later that the mask came off the patient and the patient was taken to the hospital.A review of the device's downloaded event log was completed by the manufacturer.On the day of the reported event, (b)(6)/2018 at 01:32:28 utc the logs indicated the device was alarming for a patient disconnect alarm condition with a duration of 1142 seconds (approximately 19 minutes).The alarm appears to have been acknowledged by the caregiver by logged audio pause key presses.At 10:08:03 utc, the device was again alarming for a patient disconnect alarm condition with a duration of 9180 seconds (approximately 153 minutes).At 13:00:40 utc the alarm was acknowledged by an audio pause key press.The device continued to alarm for patient disconnect alarm condition until the device was powered off at 15:40:09 utc when the device was powered off by the logged power off key press steps.The intended use for the bipap a40 states," the bipap a40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with obstructive sleep apnea (osa), respiratory insufficiency, or respiratory failure.It is intended to be used in home, institutional/ hospital, and portable applications such as wheelchairs and gurneys.It is not intended to be used as a transport ventilator, and is not intended for life support." the manufacturer concludes the device operated and alarmed to design specifications.The device did not cause or contribute to the patient's death.
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