MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Obstruction of Flow (2423)

Patient Problem Cardiac Arrest (1762)

Event Type  Death  

Manufacturer Narrative

(b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the healthcare facility reported that the subject device would not be available for evaluation and was not able to be returned.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the device gave an occlusion alarm, however, no blockage was found when checked by the medical staff.The healthcare facility also reported that the patient suffered from cardiac arrest at the time of the occlusion alarm.The patient was given cpr for 11 minutes and was declared deceased.It was further reported by the healthcare facility that the patient, who was on four-hour observations, had sudden acute deterioration with increased oxygen requirements on the day of the reported event.Conclusion: without the return of the subject device, we are unable to determine the cause of the reported event.As there was no blockage identified at the time of the reported event, the possible cause was likely temporary in nature, such as compression of the heated breathing tube or patient interface by patient movement.It is possible, that during observation by medical staff, whatever was obstructing the flow may have been moved.All airvo 2 undergo inspection during production.The subject airvo 2 would have met the required specification at the time of production.The airvo 2 user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support." our user instructions which accompany the airvo 2 state the following: appropriate patient monitoring must be used at all times.Never operate the unit if it is not working properly.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a 75 year old patient deceased from a cardiac arrest while on a pt101 airvo 2 humidifier (airvo 2).The patient was given cpr for 11 minutes.It was reported by the healthcare facility that the subject airvo 2 generated an occlusion alarm at the time of the patient's cardiac arrest, however, no blockage was found when checked by the medical staff.The healthcare facility further reported that the patient, who was on four-hour observations, had sudden acute deterioration with increased oxygen requirements on the day of the reported event.The healthcare facility also reported that the subject device would not be available for evaluation and was not able to be returned.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16038987
• MDR Text Key: 306044443
• Report Number: 9611451-2022-01151
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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): Death
• Patient Age: 75 YR