MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently in the process of investigation to determine the involvement of our product in the reported event.We will provide a follow up report upon completion of the investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the pt101 airvo 2 humidifier shut off while being used on a patient.The patient oxygen saturation level decreased to 70% spo2.No further patient consequences were reported.

Event Description

A healthcare facility in texas reported via a fisher & paykel healthcare field representative that the pt101 airvo 2 humidifier shut off while being used on a patient.The patient oxygen saturation level decreased to 70% spo2.The patient oxygen saturation improved to 95% following placement on non-rebreather mask.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 device was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the complaint pt101 airvo 2 unit shut off while being used on a patient.It was further reported by the customer that once the airvo 2 unit was restarted, it operated without any issues.Conclusion: without the complaint device, we are unable to determine what caused the reported event.Based on the additional information provided by the customer and our knowledge of the product, the most likely cause of the airvo 2 humidifier switching off was due to a disruption of the power source to the airvo 2 humidifier.The pt101 airvo2 humidifier user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply".The airvo2 user manual states that "when the unit has been disconnected from the mains/utility power socket the auditory alarm will sound for at least 120 seconds.If power is reconnected in this time, the unit will automatically restart" the airvo2 user manual also states following warnings: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 11059263
• MDR Text Key: 223373446
• Report Number: 9611451-2020-01161
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other