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

Model Number PT101

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/19/2022

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, including the sequence events, how the device failed and the patient's condition.We have also requested the return of the subject pt101 airvo 2 humidifier to f&p new zealand 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 australia reported that a pt101 airvo 2 humidifier failed during use.The healthcare facility reported that the patient was observed to have desaturated to 79% spo2 following mobilization in bed.In response, the fio2 was increased however the patient did not improve.A "code blue" was called and the patient was reviewed by an icu consultant.The patient was provided alternative treatment with a non-rebreather mask and the patient's saturation levels improved.The subject airvo 2 device was replaced with a new device and the patient's saturation levels were stabilised.No further patient consequences were reported.As per the healthcare facility's incident report, the reported injury was deemed by the healthcare facility as being minor and temporary in nature.Further information regarding the reported event including the sequence events, how the device failed and the patient's condition has been requested from the healthcare facility.

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.Further information regarding the reported event including the device set-up details, and the patient's condition was requested from the healthcare facility, however the healthcare facility was unable to provide this.An investigation was carried out by f&p which was based on the initial 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: a patient desaturated to 79% spo2 following mobilization in bed.Mobilization is the use of positioning/repositioning exercises and physical activity in bed to support the rehabilitation and recovery for bed-bound patients.In response to the patient desaturating, the fio2 was increased, however the patient did not improve and a "code blue" was called.The patient was provided alternative therapy via a non-rebreather mask and their saturation levels improved.The subject airvo 2 device was replaced, and the patient was stabilised.Visual inspection of the returned device revealed no signs of impact damage to the case.A review of the device log revealed that the e122 error code and "check for leaks" warning were logged.The returned device was performance tested across a range of flow settings and was found to reach the target flow for all settings.No interruptions or error codes were triggered.The device performed as intended and the reported fault could not be replicated.Conclusion: an e122 error code and "check for leaks" alarm, which include both visual and audible alerts, are a result of the airvo 2 detecting a leak in the system.Possible causes of the e122 error code and "check for leaks" alarm triggering include the water chamber being incorrectly pushed into place, or the heated breathing tube or patient interface being incorrectly attached.Based on the healthcare facility's report that the patient desaturated following mobilization in bed, it is possible that during the procedure, parts of of the airvo 2 system set-up, such as the heated breathing tube or patient interface became disconnected.This could have resulted in a leak in the system and a decrease in air flow.However, further information regarding the device set-up details and sequence of events was not provided.It should be noted that there was no malfunction found with the returned device during evaluation.The airvo 2 humidifier user manual states: "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." "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.".

Event Description

A healthcare facility in australia reported that a pt101 airvo 2 humidifier was providing reduced air flow during use.The healthcare facility reported that the patient was observed to have desaturated to 79% spo2 following mobilization in bed.In response, the fio2 was increased however the patient did not improve.A "code blue" was called and the patient was reviewed by an icu consultant.The patient was provided alternative treatment with a non-rebreather mask and the patient's saturation levels improved.The subject airvo 2 device was replaced with another airvo 2 device and the patient's saturation levels were stabilised.No further patient consequences were reported.As per the healthcare facility's incident report, the reported injury was deemed by the healthcare facility as being minor and temporary in nature.Further information regarding the reported event including the device set-up details, sequence of events and the patient's condition was requested from the healthcare facility, however the healthcare facility was unable to provide this.

• 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: 15171978
• MDR Text Key: 297311782
• Report Number: 9611451-2022-00712
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012447333
• UDI-Public: (01)09420012447333(10)2101238127(11)200815
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: 2101238127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2020
• 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