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

Model Number PT101

Device Problem Unexpected Shutdown (4019)

Patient Problems Hyperventilation (1910); Tachycardia (2095); Low Oxygen Saturation (2477)

Event Date 09/24/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation and have requested for the complaint device to be returned 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 on (b)(6) 2023 a pt101 airvo 2 humidifier stopped working during use, causing the patient's condition to deteriorate.It was reported that the patient was tachypnoeic and tachycardic and was treated with cpap/niv.No further patient consequences were reported.Fisher & paykel healthcare (f&p) has requested further information from the healthcare facility, including the subject device and set-up.

Event Description

A healthcare facility in australia reported that on (b)(6) 2023 a pt101 airvo 2 humidifier stopped working during use, causing the patient's condition to deteriorate.It was reported that the patient was tachypnoeic and tachycardic and was treated with cpap/niv.No further patient consequences were reported.

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.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 pt101 airvo 2 humidifier was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected, and performance tested by a trained f&p employee.F&p's investigation is based on evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and knowledge of the product.Results: visual inspection of the pt101 airvo 2 humidifier revealed no signs of impact damage externally and to the outer casing.A review of the device fault log found no error codes or warnings triggered on the day of the reported event.Performance testing of the subject device was conducted for multiple hours to attempt to replicate the reported fault, however no error codes were generated, and the unit ran as expected.The unit was opened for further inspection and no defects on the control and the power pcbs were observed.All other internal components were found to be in good condition.Conclusion: f&p's investigation was unable to determine the cause of the reported malfunction, as the reported fault was unable to be replicated.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification.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 therefore would have met the required specifications.The airvo 2 user instructions (ui) state that if the unit has been disconnected from the mains/utility power socket, an auditory alarm will sound for at least 120 seconds.The airvo 2 ui also provides the following warnings: "appropriate patient monitoring must be used at all times.Loss of power means loss of therapy." "the unit is not intended for life support." "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." "never operate the unit if it is not working properly.".

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY 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: 18238954
• MDR Text Key: 329387075
• Report Number: 9611451-2023-01093
• Device Sequence Number: 1
• Product Code: BTT
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 2101828573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• 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