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

Model Number PT101

Device Problems Connection Problem (2900); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation and is seeking further information from the healthcare facility.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 france reported via a fisher and paykel healthcare (f&p) field representative that on 12 october 2023 a pt101 airvo 2 humidifier generated an error code e26 on the sixth day of patient use.The healthcare facility reported that the patient desaturated to 45 percent spo2 for a few minutes.The staff immediately changed the device with a new circuit and then the patient's saturation returned to the satisfactory level after ten minutes.Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation and is seeking further information from the healthcare facility.

Event Description

A healthcare facility in france reported via a fisher and paykel healthcare (fph) field representative that on (b)(6) 2023, a pt101 airvo 2 humidifier generated the error code e26 after five days of patient use.The healthcare facility reported the patient had covid-19 and desaturated to 45% spo2 at the time the error code was generated.It was reported that supervising staff immediately replaced the heated breathing tube (hbt) attached to the airvo 2 and that the patient's saturation levels returned to a satisfactory level after 10 minutes.No further patient consequences were reported.

Manufacturer Narrative

Ps433802.Product background: the airvo 2 humidifier device is an active humidifier.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 works in accordance with the heated breathing tube (hbt), a detachable component that allows delivery of respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The reported error code, e26, is a hbt related error code.The e26 error code may be triggered either where there is a fault in the hbt and/or if the hbt is not correctly attached during use.The airvo 2 humidifier continuously monitors the hbt connection.When the monitoring detects a failure in connection, the e26 error code is triggered.In such a case, the airvo 2 generates both an audible and visual alarm.Method: fph requested the return of the relevant airvo 2 and hbt for investigation.The hbt was returned to the fph nz office.However, the healthcare facility did not return the airvo 2 device with reason that the airvo 2 passed all of their performance checks and the fault could not be replicated.As a result, the device was put back into service by the healthcare facility and was therefore not returned as requested.Our investigation is based on the information provided by the healthcare facility, our evaluation of the returned hbt, previous investigations of similar complaints, and our knowledge of the product.Results: the returned hbt was visually inspected and found to be in good condition.The subject hbt was then tested using an airvo 2 for several hours, no warnings or errors were generated and the complaint hbt was found to operate as expected.The reported fault could not be replicated.The healthcare facility reported that the subject airvo 2 used with the returned hbt passed all performance checks and was put back into service.The healthcare facility also reported that the patient saturation recovered following the reported event and reported that no further consequences.Conclusion: the cause of the reported event was unable to be determined through fph's investigation.The airvo 2 will provide both a visual and audible alarm to alert the user to any warnings or errors.The user instructions which accompany the airvo 2 provide guidance on troubleshooting error codes and alarms generated by the device.The user instructions also state the following: "alarm conditions that affect oxygen delivery require an immediate response to assess the patient's saturation levels" "the unit is not intended for life support" "appropriate patient monitoring must be used at all times" "never operate the unit if the heated breathing tube has been damaged with holes, tears or kinks" "make sure the blue connector if fully located into place" when installing the hbt all hbts as part of the 900pt561 heated breathing tube and chamber kit are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The hbt are 100% visually inspected using a camera system.The hbts are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The hbt would have met the required specifications at the time of production.

• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18194250
• MDR Text Key: 328824658
• Report Number: 9611451-2023-01073
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2101374811(11)201106
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2101374811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• 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
• Treatment: 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT
• Patient Outcome(s): Other
• Patient Age: 73 YR