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

Model Number PT101

Device Problem Use of Device Problem (1670)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.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 north carolina reported via a fisher and paykel healthcare (f&p) field representative that a patient moved to stand up, the fio2 on the pt101 airvo 2 dropped from 60% to 30% and the healthcare staff were not able to readjust the fio2.The patient desaturated to 74% for about 5 minutes, the patient was placed on a non-rebreather mask while another airvo 2 was setup.It was reported that the patient was taken to icu due to the patient's slow recovery.No further patient consequence was reported.It was further reported by the healthcare facility that the issue was most likely a third-party flowmeter and not the pt101 airvo 2 device.F&p asked the healthcare facility to return the subject device for investigation.The healthcare facility stated that the airvo 2 was performance checked by them, it passed all checks and was put back into service therefore it would not be returned.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 has not provided this information.

Event Description

A healthcare facility in north carolina reported via a fisher and paykel healthcare (f&p) field representative that when a patient moved to stand up, the fio2 on the airvo 2 dropped from 60% to 30% and the healthcare staff were unable to readjust the fio2.The patient desaturated to 74% for about 5 minutes and the patient was placed on a non-rebreather mask while another airvo 2 was setup.It was reported that the patient was subsequently taken to icu due to the patient's slow recovery.No further patient consequence was reported.It was further reported by the healthcare facility that the issue was most likely caused by a third-party flowmeter and not the airvo 2 device.F&p asked the healthcare facility to return the subject device for investigation.The healthcare facility stated that the airvo 2 passed all of their performance checks and was put back into service, therefore the device would not be returned.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 has not provided this information.

Manufacturer Narrative

(b)(4).Product background: the 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.Method: the complaint airvo 2 was not returned to fisher & paykel healthcare (f&p) for evaluation, the healthcare facility stated that the airvo 2 passed all of their performance checks and was put back into service, therefore the device would not be returned.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility stated that when a patient moved to stand up, the fio2 on the airvo 2 dropped from 60% to 30% and the healthcare staff were not able to readjust the fio2.The patient desaturated to 74% for about 5 minutes, the patient was placed on a non-rebreather mask while another airvo 2 was setup.It was reported that the patient was taken to icu due to the patient's slow recovery.No further patient consequence was 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 has not provided this information.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, the healthcare facility stated that the airvo 2 passed all of the healthcare facility's performance checks and was put back into service.The healthcare facility also stated that the issue was most likely caused by a third-party flowmeter and not the airvo 2 device.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification and are performed at the end of the final assembly process on 100% of manufactured units.Any unit that fails any of these tests will be rejected.The subject airvo 2 would have met the required specifications.The airvo 2 humidifier user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." additionally, the user manual also warns the user: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.

• 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: 15858318
• MDR Text Key: 304275962
• Report Number: 9611451-2022-01005
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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: 2101434756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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