MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 06/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving the subject pt101 airvo 2 humidifier for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 23% spo2, experienced obtundation and was bradycardic at 15 bpm when the pt101 airvo 2 humidifier stopped providing flow.The patient was manually ventilated using a bag valve mask.The "patient responded quickly to manual ventilation and spo2 improved to 99%".No further patient consequence was reported.

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 23% spo2, experienced obtundation and was bradycardic at 15 bpm when the pt101 airvo 2 humidifier, set to 50lpm and 70% fio2, "stopped working and displayed message 'please turn off and restart'".The patient was manually ventilated using a bag valve mask and recovered to a stable condition at 99% spo2.There was no further patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected, and performance tested.Results: visual inspection of the returned subject pt101 airvo 2 humidifier revealed no signs of external or impact damage.The error logs were reviewed showing that e192 error code was logged approximately at the time of the event.The unit was powered on, ran for four continuous hours and was found to be working correctly, with no error codes displayed.The subject device was opened for further investigation revealing no issues with the internal components of the unit.Conclusion: we are unable to determine what may have caused the disruption in therapy, as there was no fault found with the returned device.An e192 error code occurs when there is noise detected in the oxygen readings of the sensor.Flow continues to be delivered when e192 error code occurs.When it is triggered, an audible alarm will sound and a visual alarm will display "please turn off and restart".The airvo 2 humidifier user manual states: - "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" - "the unit is not intended for life support." the user manual warns the user: - "appropriate patient monitoring must be used at all times.".

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 12038045
• MDR Text Key: 257372464
• Report Number: 9611451-2021-00688
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 150831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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
• Treatment: O2 FROM THE WALL VIA FLOWMETER; OPTIFLOW NASAL CANNULA; OPTIFLOW NASAL CANNULA; OPTIFLOW NASAL CANNULA
• Patient Outcome(s): Other