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 12/17/2023

Event Type  Injury  

Event Description

On 03 january 2024, a healthcare facility in turkey reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated an alarm during patient use.The healthcare facility reported that the patient desaturated after the alarm was generated.The healthcare facility later reported that the staff replaced the device and the patient's spo2 improved.Additionally, the healthcare facility stated on (b)(6) 2024 that the patient desaturated to spo2 between 60% and 62%.The staff provided an oxygen mask and moved the patient to another device during which the patient further desaturated to spo2 between 50% and 55% for ten minutes.On 17 january 2024 the healthcare facility provided additional information that after the subject device was replaced, the patient's spo2 improved to acceptable levels.However, it was also stated on (b)(6) 2024 that the patient had passed five days after this event.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.

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 2humidifier (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.

Manufacturer Narrative

(b)(4), corrected data: b5,e1,g3,h6 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 where it was inspected by a trained f&p investigation engineer.The device was performance tested and the device log was reviewed.F&p's investigation is based on the information provided by the customer, f&p's evaluation of the subject device, previous investigations of similar complaints, and f&p's knowledge of the product.Results: visual inspection of the subject device revealed that the heated breathing tube connection port of the subject device was deformed, and the display and finger guard were also damaged.The subject device was opened for further investigation revealing signs of internal water damage.The device log was downloaded and confirmed that the subject device had recorded the error code e1 on the day of the event.When the device was tested as part of f&p's investigation to generate the error code e1, the error code was then displayed on the screen and an audible alarm sounded.During the investigation process, the motor of the subject device did not start.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 unit 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'.The healthcare facility reported that the patient desaturated to spo2 between 60% and 62%.After the subject device's alarm was generated.It was reported that the staff provided an oxygen mask and moved the patient to another device during which the patient further desaturated to spo2 between 50% and 55% for ten minutes.The healthcare facility later reported that the staff replaced the device and the patient's spo2 improved.The healthcare facility later reported that the patient had passed five days after this event.Conclusion: the exact cause of the observed damage to the subject device was unable to be determined through f&p's investigation.Based on f&p's knowledge of the product, the error code e1 was likely due to internal water ingress and the observed impact damage, which can occur due to being dropped or an excessive force being applied to the subject device.The healthcare facility reported that the subject device provided 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 it is not working properly" -"never operate the unit if it has been dropped or damaged" -"never operate the unit if it has been dropped into water" -"if water has entered the unit enclosure, disconnect the power cord and discontinue use".

Event Description

On (b)(6) 2024, a healthcare facility in turkey reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated an alarm during patient use.The healthcare facility reported that the patient desaturated after the alarm was generated.The healthcare facility later reported that the staff replaced the device and the patient's spo2 improved.Additionally, the healthcare facility stated on (b)(6) 2024 that the patient desaturated to spo2 between 60% and 62%.The staff provided an oxygen mask and moved the patient to another device during which the patient further desaturated to spo2 between 50% and 55% for ten minutes.On 17 january 2024 the healthcare facility provided additional information that after the subject device was replaced, the patient's spo2 improved to acceptable levels.However, it was also stated on (b)(6) 2024 that the patient had passed five days after this event.

• 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: 18673547
• MDR Text Key: 334946653
• Report Number: 9611451-2024-00083
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 01/12/2024

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: 2101445332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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
• Patient Age: 10 MO