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

Model Number PT101

Device Problems Loss of Power (1475); Complete Loss of Power (4015)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 09/23/2022

Event Type  Death  

Event Description

(b)(6) 2022 a healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2022 a pt101 airvo 2 humidifier (airvo 2) was inadvertently unplugged from its power supply during use.The healthcare facility also reported that the power-out alarm could not be heard when the device was unplugged.On (b)(6) 2023 f&p was notified that at the time of the reported event the patient receiving therapy via the subject airvo 2 rapidly deteriorated and subsequently passed away.F&p have requested further information about the reported event including the sequence of events and medical cause of death.

Manufacturer Narrative

(b)(4).F&p are in the process of completing our investigation.Further information about the reported event including the sequence of events and medical cause of death have been requested.We will provide a follow up report upon completion of our investigation.The airvo 2 user instructions states the following: - "appropriate patient monitoring must be used at all times.Loss of power means loss of therapy." - "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" - "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.".

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 device was not returned to fisher & paykel healthcare (f&p) for evaluation.F&p requested further information about the reported event including the sequence of events and medical cause of death.The healthcare facility did not provide any further information despite f&p making several requests for this information.Our investigation is based on the initial information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the device was inadvertently unplugged from its power supply during use.The healthcare facility further reported that the patient rapidly deteriorated and subsequently passed away at the time of the event.Conclusions: without the return of the subject device or further information about the reported event f&p are unable to determine the cause of the reported event.Without a power source the airvo 2 will not provide therapy to the patient.The airvo 2 will provide an audible alarm for at least 120 seconds when the power supply to the device is lost.Without the return of the subject device, we are unable to confirm the alarm functionality of the subject device.The airvo 2 user instructions provide guidance on testing the alarm system functionality and state that "prior to each patient use ensure that the auditory alarm signal is audible" and that if "alarm signal is absent, do not use the unit".The user instructions also state the following: "the unit is not intended for life support." "appropriate patient monitoring must be used at all times.Loss of power means loss of therapy." "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." during the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification including functional testing to verify speaker performance.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 would have met the required specifications.

Event Description

On 29 september 2022 a healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2022 a pt101 airvo 2 humidifier (airvo 2) was inadvertently unplugged from its power supply during use.The healthcare facility also reported that the power-out alarm could not be heard when the device was unplugged.On (b)(6) 2023 f&p was notified that at the time of the reported event the patient receiving therapy via the subject airvo 2 rapidly deteriorated and subsequently passed away.F&p requested further information about the reported event including the sequence of events and medical cause of death.The healthcare facility did not provide any further information despite f&p making several requests for 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 ; 9494534000
• MDR Report Key: 16916310
• MDR Text Key: 315063029
• Report Number: 9611451-2023-00437
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: 2101771530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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): Death