(b)(4) method: the complaint (b)(4) respiratory humidifier was not returned to fisher & paykel healthcare in (b)(6) for evaluation.Further information about the reported event was requested from the customer, however limited information was provided.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: a healthcare facility in (b)(6) reported via the nmpa reporting system that a patient became hypoxemic when they developed a mucus plug in the airway while using a (b)(4) respiratory humidifier.It was noted a "see manual" indicator was flashing on the device.There was no further patient consequence reported.Conclusion: without the complaint device, we were unable to determine the cause of the reported event.The see manual indicator is a feature that notifies the user to respond to a condition with the (b)(4).Ventilation therapy continues to be delivered to the patient when the see manual indicator is triggered.All (b)(4) respiratory humidifiers undergo functional testing during production to verify the proper functioning of the device.The subject (b)(4) respiratory humidifier would have met the required specification at the time of production.The user instructions accompanying the (b)(4) state the following: if the red light is illuminated, the humidifier and all accessories should be immediately removed and sent for servicing.
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