It was reported by the patient that, while riding in the car, she started to feel ill and her o2 levels allegedly dropped.The patient went to the hospital to seek medical attention.Inogen is currently pending the receipt of the medical records for this report.Inogen will write a supplemental filing with any additional information gathered.A failure investigation report was initiated to determine the cause of the alleged malfunction.The investigation concluded that the device was functioning as intended and no device malfunction occurred.It was also confirmed that the auto-pulse function on the device, intended to deliver oxygen at a fixed rate based on setting in the event that a breath is not detected, was working as intended.
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It was reported by the patient that, while riding in the car, she started to feel ill and her o2 levels allegedly dropped.When this occurred, her husband drove her to the hospital.
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