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

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is 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)(6) for evaluation.We will provide a follow up report upon completion of our investigation.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.It's 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.

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel representative that a pt101 airvo 2 humidifier stopped providing air flow during use.It was reported that the patient became cyanotic (spo2 68%).The patient was immediately provided oxygen via a non-rebreather mask, and their saturation levels returned to normal immediately.It was reported by the healthcare facility that clinical staff observed air flow from the subject airvo 2 after the patient was disconnected from the device.The subject airvo 2 was then replaced.There were no further patient consequences reported.It is unknown if there is any causal relationship between the subject device and the patient condition.Further information has been requested regarding the reported event including the sequence of events.

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 performance tested.An investigation was carried out by f&p which was based on the information provided by the healthcare facility, a field visit conducted at 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: on (b)(6) 2022, a paediatric patient was moved to the ward from the picu and placed on an airvo 2 which was set to 11l/min flow and 21% fio2 in junior mode.The healthcare facility reported that within a short time frame of starting therapy, clinical staff noticed that they could not hear any air flow coming from the nasal prongs and the patient became cyanotic with their spo2 levels measuring at 68%.The patient was provided alternative therapy via a non-rebreather mask at 10l and their spo2 levels returned to normal immediately.The patient was disconnected from the subject airvo 2 and set up on a new airvo 2, and no further patient consequences were reported.The healthcare facility reported that after the patient was disconnected from the subject airvo 2, air flow from the airvo 2 tubing was observed by clinical staff.A review of the device log confirmed that the "check for leaks" warning was logged.The returned device was performance tested across a range of flow settings, including the reported settings, and the reported fault could not be replicated.The device performed as intended.The unit was opened for further investigation and no defects were observed that could have resulted in the reported fault.Following the reported incident, a f&p field representative visited the healthcare facility.During the field visit, the f&p field representative reported observing that clinical staff were incorrectly setting up an airvo 2 device on site.The incorrect set up which was observed was that the chamber was not fitted correctly to the airvo2 device chamber ports, allowing a leak to occur.It was also observed that clinical staff did not check that the chamber was positioned correctly to create a seal prior to start up.This is not in accordance with the airvo 2 user instructions.It was also observed that no audible flow could be heard from the nasal prongs set up with the same airvo 2 device after starting up and the "check for leaks" alarm was triggered from the airvo 2 device after approximately two minutes.Clinical staff confirmed that the reported medical response would have occurred before the alarm could trigger.Further information regarding the reported event including the sequence of events and patient's condition was requested from the healthcare facility, however, the healthcare facility was unable to provide this information.Conclusion: although we are unable to determine the cause of the reported event, based on the information provided by the healthcare facility and f&p field representative, it is likely that a leak occurred between the chamber and the airvo 2 unit, as a result of an incorrect set up, thus resulting in the loss of air flow.This is also supported by the observation that the "check for leaks" alarm was recorded in the device log.The "check for leaks" alarm, which includes both visual and audible alerts, is a result of the airvo 2 detecting a leak in the system and is triggered within two minutes of detection of a leak.The "check for leaks" alarm was most likely caused by the water chamber being incorrectly set up and not fully pushed into place.There was no malfunction found with the returned device during evaluation.The f&p field representative has since provided further education and training to clinical staff around the correct set-up and usage of the airvo 2 system.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 to ensure there are no leaks in the airpath.Flow and oxygen sensors are calibrated and checked for accuracy.- 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 device has met the required specifications.The airvo 2 humidifier user manual states: - "fit the water chamber to the unit by pressing down the finger guard and sliding the chamber on, carefully aligning with the blue chamber port ends.Push the chamber on firmly until the finger guard clicks into place." - "do not start the unit without the water chamber in place." - "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." - 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.".

Event Description

A healthcare facility in australia reported via a fisher and paykel representative that a pt101 airvo 2 humidifier stopped providing air flow during use.It was reported that the patient was cyanotic (spo2 68%).The patient was immediately provided oxygen via a non-rebreather mask, and their saturation levels returned to normal immediately.The subject airvo 2 was then replaced.There were no further patient consequences reported.Further information regarding the reported event including the sequence of events and patient's condition was requested from the healthcare facility, however, the healthcare facility was unable to provide this information.

• 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: 14725848
• MDR Text Key: 294784815
• Report Number: 9611451-2022-00555
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012447333
• UDI-Public: (01)09420012447333(10)2101734141(11)210729
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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: 2101734141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• 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
• Patient Outcome(s): Other