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

Model Number PT101

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

Patient Problem Low Oxygen Saturation (2477)

Event Type  Death  

Manufacturer Narrative

(b)(4).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.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the airvo 2 was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: based on the information provided by the healthcare facility, it is concluded that there was no malfunction of the f&p airvo 2 humidifier during the reported event.The healthcare facility confirmed that the incident was caused due to a failure to monitor the dials on the oxygen cylinders, which indicate the remaining oxygen supply.This action would have alerted staff of the insufficient oxygen in the cylinder.The limited number of oxygen ports per bed was also mentioned as a contributing factor by the healthcare facility.Furthermore, the healthcare facility stated that the cause of the patient's death was likely to be covid-19 pneumonia, potentially exacerbated by aspiration pneumonia secondary to the brief hypoxic episode at the time the oxygen supply was stopped.Conclusion: f&p has therefore established that there is no causal relationship between the reported event and the subject airvo 2 humidifier.There is no indication that the subject airvo 2 humidifier has contributed to the reported event.The airvo 2 humidifier user manual states: "appropriate patient monitoring must be used at all times." "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" "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 london reported that, on (b)(6) 2021, a 64-year-old female patient with covid-19 was receiving nasal high flow oxygen from a fisher & paykel healthcare (f&p) airvo 2 humidifier which was connected to an oxygen cylinder at the time of the event.As the oxygen cylinder ran out of oxygen, the patient experienced a peri-arrest.The therapy was then restored, however the healthcare facility stated that the patient continued to deteriorate over the next few days and deceased three days later on the (b)(6) 2021.The healthcare facility reported the following sequence of events: on (b)(6) 2021, a patient was admitted to the hospital with covid-19 pneumonia, and then developed type ii respiratory failure.Initial treatment consisted of high flow oxygen delivered through non-invasive ventilation (niv) using non-f&p devices.At 10:15 am on that same day, the oxygen supply was temporarily switched from the wall oxygen supply to an oxygen cylinder due to a pipeline oxygen issue.Once the wall oxygen supply was restored, the patient continued to receive niv therapy using the wall oxygen supply.At lunch time, the patient's treatment was changed to nasal high flow oxygen with a f&p airvo 2 humidifier.However, the airvo 2 humidifier was connected to the oxygen cylinder rather than the wall oxygen supply.The oxygen cylinder ran out of oxygen while in use by the patient.At 13:30 pm the patient experienced a peri-arrest and was found hypoxic while still wearing a nasal cannula.The high flow oxygen treatment delivered by the airvo 2 humidifier was then restarted, however the patient vomited and aspirated.Following these events, the patient was treated for hypoxia and was also administered antibiotics (iv) for possible aspiration pneumonia.The patient continued to deteriorate over the next few days and deceased three days later on the (b)(6) 2021.The healthcare facility did not report any malfunction with the subject airvo 2 humidifier.According to the healthcare facility, the cause of patient's deterioration was failure to monitor the dials on the oxygen cylinders indicating the remaining oxygen supply, which would have alerted staff of the insufficient oxygen in the cylinder.It was stated that the likely cause of patient's death was covid-19 pneumonia, potentially exacerbated by aspiration pneumonia secondary to the brief hypoxic episode at the time the cylinder ran out of oxygen.The healthcare facility attributed the event to the higher demand in the use of high flow oxygen devices during the covid-19 pandemic.The limited number of oxygen ports per bed was also mentioned as a contributing factor by the healthcare facility.

• 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 ; 9494534000
• MDR Report Key: 17045203
• MDR Text Key: 316380125
• Report Number: 9611451-2023-00511
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/04/2023
• 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
• Patient Age: 64 YR