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

Model Number PT101

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject pt101 airvo 2 humidifier to f&p (b)(4) 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 and paykel representative that an pt101 airvo 2 humidifier would not reach the prescribed air flow without alarming with an error notification.The airvo 2 humidifier was being used in adult mode for a paediatric patient.The patient experienced worsening respiratory conditions, they were then provided with alternative oxygen therapy and placed on a new airvo 2 humidifier.Once the patient had been stabilised on oxygen therapy they were transferred to the paediatric icu (picu) for further management.There were no further reported patient consequences.

Event Description

A healthcare facility in australia reported via a fisher and paykel representative that a patient requiring "higher oxygen therapy" was placed on a pt101 airvo 2 humidifier (airvo 2) device.The healthcare facility stated that the airvo 2 device did not reach the prescribed air flow therapy and alarmed with a "check for blockage" warning.The patient experienced worsening respiratory conditions and was placed on a non-rebreather mask.Once the patient was stabilized on oxygen therapy, the patient was transferred to the pediatric icu (picu) for further management.There were no further reported patient consequences.Further information regarding the reported event including the device setup, sequence events and the patient's condition was requested from the healthcare facility.However, the healthcare facility did not provide any of the requested information despite several attempts to request this.

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.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 subject airvo 2 device was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected, and performance tested.An investigation was carried out by f&p which was based on the information provided by the healthcare facility, our evaluation of the returned device, and our knowledge of the product.Results: the healthcare facility reported the following sequence of events: a patient was placed on the subject airvo 2 after a nurse identified them as requiring "higher oxygen therapy".The airvo 2 sounded like it was increasing in flow rate, however it was unable to reach the target flow rate of 10l/min without the "check for blockages" warning triggering.The device and all connections were checked by clinical staff and no faults were observed.The patient experienced worsening respiratory conditions and was placed on a non-rebreather mask at 15l/min.Once the patient was stabilized on oxygen therapy, they were transferred to the picu for further management.The healthcare facility's biomedical engineer reported that the device was in adult mode when it was received from the department the reported event occurred in and that they were unable to replicate the reported event.The biomedical engineer further reported that the department uses the ojr416 and ojr418 optiflow junior 2 nasal cannulas.Visual inspection of the returned device performed by f&p revealed no signs of impact damage to the outer enclosure of the device.A review of the device log of the device confirmed that the "check for blockages' warning was logged.The device was performance tested in junior mode for three hours and was found to be reaching the target flow of 10l/min and maintained it for the entire testing period, with no error codes or warnings triggered.The device was opened for further investigation and all internal components were found to be in good condition.Conclusion: we are unable to determine the cause of the reported event, as there was no malfunction found with the returned device.A "check for blockages" warning occurs when the airvo 2 detects a blockage in the system.It is noted that the biomedical engineer from the healthcare facility reported that the device was received in adult mode and that the department in which the reported event occurred uses the ojr416 and ojr418 optiflow junior 2 nasal cannulas, both of which are not indicated for use with the airvo 2 in adult mode.It is therefore likely that the restriction of air flow was caused by the use of an optiflow junior nasal cannula while the airvo 2 device was in adult mode.This could have resulted in the device not reaching the prescribed air flow which could have caused the alarm for blockage to sound.When the "check for blockages" warning is triggered, an audible alarm will sound, and a visual alarm will display pictures indicating the location of the potential blockage and to assist the operator in troubleshooting.Further information regarding the reported event including the device setup, sequence events and the patient's condition was requested from the healthcare facility.However, the healthcare facility did not provide any of the requested information despite several attempts to request this.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification.The following specific controls ensure each device delivers flow as per the device performance specifications and that the unit is free from any physical damage: visual examination: each unit is visually inspected for external damage and rejected if any damage is identified.Pressure flow testing: each unit is pressure tested and flow and oxygen measurements are verified to ensure there are no leaks in the airpath.Soak and reliability testing: each unit is connected to a hbt and water chamber, and then tested to ensure it performs as intended over extended operating conditions.These quality control measures are performed at the end of the final assembly process on 100% of the manufactured units.Any unit that fails any of these tests will be rejected.The subject devices would have met the required specifications.The airvo 2 humidifier user manual states: "if the patient will be using an optiflow junior nasal interface (opt316/ojr416/opt318/ojr418), you must activate junior mode." "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." "do not connect supplementary oxygen to the airvo 2 at flow rates higher than the airvo 2 target flow rate, as excess oxygen will be vented into the surroundings, or 60l/min." "prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section.".

• 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: 14247439
• MDR Text Key: 290369010
• Report Number: 9611451-2022-00401
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012447333
• UDI-Public: (01)09420012447333(10)2101616478(11)210430
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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
• Device Lot Number: 2101616478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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: OJR416 OR OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA
• Patient Outcome(s): Required Intervention