MAUDE Adverse Event Report: AIRVO2 HUMIDIFIER

Model Number PT101

Device Problems Defective Alarm (1014); No Audible Alarm (1019); Connection Problem (2900)

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 06/05/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).We are currently in the process of determining if the pt101 airvo 2 humidifier caused or contributed to the reported event.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported that a pt101 airvo 2 humidifier displayed an error code while in use on a patient.It was later reported that there was no audible alarm when the reported error code occurred.It was further reported that the patient deceased.Following the reported incident, a fisher & paykel healthcare (f&p) representative in the united states contacted the healthcare facility in an attempt to obtain further information about the reported event.We are currently awaiting their response.

Event Description

A healthcare facility in arizona reported that a pt101 airvo 2 humidifier displayed an error code while in use on a patient.It was later reported that there was no audible alarm when the reported error code occurred.It was further reported that the patient deceased.

Manufacturer Narrative

Ps341960 f&p healthcare contacted the customer to obtain further information on the reported event and also requested the return of the subject airvo 2 humidifier.We followed up with the customer multiple times in order to obtain additional information and the complaint device as part of the root cause analysis.The customer provided additional information regarding the patient's medical history relevant to this event, the airvo 2 humidifier set up, and clarification on the event.The patient was an 83 year old male with a medical history of chronic respiratory failure with home oxygen, dvt/pe (deep vein thrombosis and pulmonary embolism), afib (atrial fibrillation), multiple myeloma, cad (coronary artery disease), htn (hypertension), hyperlipidemia, a recent left hip fracture, esrd (end-stage renal disease) and was on hd (haemodialysis).The patient tested positive for covid-19.The patient also had a 'do-not-resuscitate (dnr)' / 'do-not-intubate (dni)' order, which is a medical order written by a doctor to instruct health care providers not to perform cardiopulmonary resuscitation (cpr) if the patient's heart stops beating and/or not to intubate if a patient's breathing stops.The customer also reported that prior to the reported event, the patient's spo2 saturation was 94% and they complained of increased sob (shortness of breath).Assessment of the information provided by the hospital regarding the patient's existing medical conditions related to this event indicated that the patient was in a poor state of health.The customer reported that the patient was placed on nasal high flow therapy (airvo 2 humidifier) on the (b)(6)2020 at 02:00.The device was set to 50lpm (liters per minute) and 60% supplemental oxygen was being provided to the patient.The customer stated that the oxygen level did not need to be adjusted prior to the reported event.On the(b)(6)2020 at 00:00 the patient's pulse was 88bpm, rr (respiratory rate) (b)(4) breaths per minute and spo2 saturation was (b)(4).At this time the device was set to 60lpm and (b)(4) supplemental oxygen.On the (b)(6)2020 at 03:55 the patients pulse was 88bpm and spo2 saturation was (b)(4).The customer also reported that at some stage the patient was "unresponsive and without a pulse", however the timing around this was unclear and was not clarified by the customer.F&p healthcare followed up with the customer to obtain more information in relation to the cause of death, the timing of when the patient was found "unresponsive and without a pulse", how staff were alerted to the reported event, and the alarm settings of the patient's pulse oximeter.This information has not been made available to f&p healthcare at this time.Method: the complaint pt101 airvo 2 humidifier was received at f&p healthcare new zealand for investigation.The unit was visually inspected for defects, functionally tested for an extended period, and the device compliance log was reviewed.The information provided by the customer was also reviewed to assess the cause of the reported event.Results: during testing, the airvo 2 humidifier powered on and was found to be fully functioning.The unit ran continuously without any errors and the reported error code was not replicated during the extended period.No fault was found which could cause an error code during use.During the inspection, an incidental finding was that the audible alarm of the complaint airvo 2 humidifier was not working.Electrical resistance testing has shown the speaker's resistance to be open circuit.The customer was not able to answer questions about whether the alarm system functionality checks described in the airvo 2 user instructions were carried out prior to patient use.The visual display was functional at the time.The device compliance log provides basic information regarding the set-up of the airvo 2 humidifier.Analysis of the airvo 2 log showed that the device was set to default (adult) mode which is the correct mode for the patient based on the information provided by the customer.A review of the log identified that the reported error code (e26) occurred approximately 22 minutes before the hospital reported the patient's condition as 88bpm and (b)(4) spo2 saturation.E26 is a heated breathing tube (hbt) related error code.The airvo 2 humidifier continuously checks that the hbt is connected adequately, however when these checks detect a failure in the connection, the e26 error code is triggered.If an e26 error code occurs the airvo 2 humidifier generates both an audible and visual alarm.The error code may have been triggered due to a fault in the hbt or if the hbt was not connected correctly or became disconnected during use.The complaint hbt was not returned to f&p healthcare for investigation so the cause of the e26 error code cannot be confirmed.It was also noted that the patient was set up on the airvo 2 humidifier on the (b)(6)2020 , two days prior to the reported event on the (b)(6)2020.During this time of continuous operation there were no faults related to the heated breathing tube recorded in the compliance log.Conclusion: the airvo 2 humidifier is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 humidifier is designed to provide high flow warmed and humidified respiratory gases to spontaneously breathing patients who are not dependent on mechanical respiratory support.We are unable to determine what caused the reported error code, as the complaint hbt was not returned to f&p healthcare for investigation and when the airvo 2 was tested the device was able to be powered on and capable of delivering therapy.However, information related to the patient, indicated that the patient had severe acute respiratory failure with dnr and dni orders in place.The airvo 2 user manual states that "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." the user manual warns the user: · the unit is not intended for life support · appropriate patient monitoring must be used at all times.· use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.· never operate the unit if: - the hbt has been damaged with holes, tears or kinks - it is not working properly · do not block the flow of the air through the unit and hbt · prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarm section.The alarm system functionality check instructs the user on how to check the alarm and states that if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative." the user instructions that accompany heated breathing tube state the following: - never operate the unit if the breathing tube has been damaged with holes, tears or kinks.

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• MDR Report Key: 10318157
• MDR Text Key: 200182789
• Report Number: 9611451-2020-00643
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: 01094200124223471021000012681115101521151015021654
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 2100001268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 09/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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: F&P HEATED BREATHING TUBE
• Patient Outcome(s): Death
• Patient Age: 83 YR