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

Model Number PT101

Device Problems Device Alarm System (1012); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).Fisher & paykel healthcare (f&p) has 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

On (b)(6) 2023, a distributor reported on behalf of a healthcare facility in japan that a pt101 airvo 2 humidifier generated an error code e1 while being used on a patient.On (b)(6) 2023, the healthcare facility further reported the following sequence of events: on 27 august 2023, an error code e1 was generated on a pt101 airvo2 humidifier.It was reported the nurse in charge was late to notice the alarm on the patient monitor because the patient was in a private room with the door shut.The patient's oxygen saturation was reported to be 54% at the time the e1 error code occurred.The nurse responded to the issue by switching the patient to a reservoir mask and restarted the pt101 airvo2 humidifier and then resumed the therapy.It was reported that the patient's spo2 recovered, however the exact spo2 level was unspecified.The e1 error code occurred again after six hours.There were no further patient consequences reported.Fisher & paykel healthcare (f&p) has requested further information and for the complaint device to be returned for evaluation.

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 subject airvo 2 device was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was inspected by f&p's investigation team.The device was performance tested and the device log was reviewed.F&p's investigation is based on the information provided by the customer, the evaluation of the subject device, previous investigations of similar complaints, and f&p's knowledge of the product.The reported error code, e1, is a motor related error code.An e1 error code may occur due to multiple factors including if an airvo 2 device was dropped, shaken or exposed to water over time.When an e1 error code is triggered, an audible alarm will sound and a visual alarm will display 'fault e1', 'switch off the unit and then restart'.Results: external visual inspection of the subject device showed no signs of impact damage.The subject device was opened for further investigation revealing that the blower was found to have rusted bearings.It was found the rusted bearings were likely to have been caused by water ingress.The device log was downloaded and confirmed that the subject device had recorded the error code e1.Conclusion: based on the evaluation of the subject device, previous investigations of similar complaints, and f&p's knowledge of the product, the error code e1 was likely due to internal water ingress of the blower.The exact cause of the likely internal water ingress was unable to be determined by f&p's investigation.The healthcare facility reported that the subject device provided both a visual and audible alarm to alert the user of any warnings or errors.The user instructions which accompany the airvo 2 device 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." - "do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use." - "never operate the unit if it has been dropped into water." - "the unit is not intended for life support." - "appropriate patient monitoring must be used at all times." - "never operate the unit if it is not working properly.".

Event Description

On (b)(6) 2023, a distributor reported on behalf of a healthcare facility in japan that a pt101 airvo 2 humidifier generated an error code e1 while being used on a patient.On (b)(6) 2023, the healthcare facility further reported the following sequence of events: on (b)(6) 2023, an error code e1 was generated on a pt101 airvo2 humidifier.It was reported the nurse in charge was late to notice the alarm on the patient monitor because the patient was in a private room with the door shut.The patient's oxygen saturation was reported to be 54% at the time the e1 error code occurred.The nurse responded to the issue by switching the patient to a reservoir mask and restarted the pt101 airvo2 humidifier and then resumed the therapy.It was reported that the patient's spo2 recovered, however the exact spo2 level was unspecified.The e1 error code occurred again after six hours.There were no further patient consequences reported.

• 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 92618 ; 8007923912
• MDR Report Key: 18234231
• MDR Text Key: 329317545
• Report Number: 9611451-2023-01106
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422323
• UDI-Public: (01)09420012422323(10)2101633941(11)210512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101633941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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
• Patient Age: 77 YR