MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO AIRSPIRAL TUBE; BTT

Model Number 900PT560E

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 02/12/2023

Event Type  Injury  

Event Description

On 06 april 2023 a respiratory care provider in ohio reported via a fisher and paykel healthcare (f&p) field representative that on (b)(6)2023 a 15 month old patient sustained a second degree burn on their left thigh, approximately 8 inches long and 2 inches wide, while using a 900pt560e myairvo airspiral tube.The patient reportedly received burn care in hospital and was discharged home on the same day as the event.The respiratory care provider also reported on 06 april 2023 that the patient passed away on (b)(6)2023 from a cardiac arrest.The patient reportedly had a history of sudden cardiac arrest and chronic respiratory failure.The respiratory care provider reported that the patient death was unrelated to this event.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the myairvo airspiral tube (airspiral) is a component designed for use with the myairvo 2 humidifier (myairvo 2), for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The airspiral as part of the myairvo 2 system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimizing the amount of condensate in the tube.The myairvo airspiral tube user instructions state the following: "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time.", "do not add heat to any part of the breathing tube e.G.Covering with a blanket.".

Manufacturer Narrative

(b)(4).Corrected data: g1 updated.Product background: the 900pt560e myairvo airspiral tube is a heated breathing tube (hbt) designed for use with the myairvo 2 humidifier (myairvo 2), for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The hbt as part of the myairvo 2 system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimizing the amount of condensate in the tube.Method: the subject hbt was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the respiratory care provider, including photos of the patient's injury, and our knowledge of the product.Results: the respiratory care provider reported that the patient received a second degree burn on their left thigh while using the hbt.The patient received care in hospital on the day of the burn.Information on the length of use, position, or any damage to the beathing tube could not be provided by the respiratory care provider.The respiratory care provider also reported that the patient passed away two days later from a cardiac arrest.The patient reportedly had a history of sudden cardiac arrest and chronic respiratory failure.The respiratory care provider reported that the patient death was unrelated to this event.Conclusion: without the return of the subject hbt or further information on the device setup, f&p are unable to confirm the cause of the reported event.The 900pt560e myairvo airspiral tube user instructions show in pictorial format the correct placement of the device and includes the following information: - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." - "do not add heat to any part of the breathing tube e.G.Covering with a blanket." based on our knowledge of the product and the photos provided which illustrated bedding near the patient, it appears likely that the burn was a result of the patient having direct skin contact with the hbt for a prolonged period as well as possibly being covered by clothing or bedding.All hbt are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The heated breathing tubes are 100% visually inspected using a camera system.The hbt are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The surface temperature of the hbt, when used in accordance with user instructions, is designed to be within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.As is required under iso 80601, the user instructions for the hbt contains the warning "do not add heat to any part of the breathing tube e.G.Covering with a blanket," additional "do not cover" tags are also attached to all hbt to alert the user that the hbt should not be covered.There are many safety features incorporated into the myairvo 2 system to prevent overheating and fire.These include: - the heater wires in the hbt are completely insulated from the gas path.- the pcb at the patient end of the hbt is over moulded with the thermoplastic polymer polypropylene, ensuring it is excluded from the gas path.- the myairvo 2 device contains technology which detects short circuits and transient current events in the hbt.When detected, the myairvo removes power to the hbt.The myairvo 2 performs this detection at any time it is turned on and connected to an hbt.This functionality is checked by the control system each time the myairvo is powered up, or when a new hbt is connected.- an 'over-temperature' sensor will automatically cut power to the motor, heater plate and heater wire if it detects any overheating at the chamber or the patient end of hbt.- the myairvo 2 device continuously checks power in the hbt and disables the heater wire if the measured power is too high.

Event Description

On (b)(6) 2023 a respiratory care provider in ohio reported via a fisher and paykel healthcare (f&p) field representative that on (b)(6) 2023 a 15 month old patient sustained a second degree burn on their left thigh, approximately 8 inches long and 2 inches wide, while using a 900pt560e myairvo airspiral tube.The patient reportedly received burn care in hospital and was discharged home on the same day as the event.The respiratory care provider also reported on (b)(6) 2023 that the patient passed away on (b)(6) 2023 from a cardiac arrest.The patient reportedly had a history of sudden cardiac arrest and chronic respiratory failure.The respiratory care provider reported that the patient death was unrelated to this event.

• Brand Name: MYAIRVO AIRSPIRAL TUBE
• Type of Device: BTT
• 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: 16873994
• MDR Text Key: 314625385
• Report Number: 9611451-2023-00414
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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: Lay User/Patient
• Device Model Number: 900PT560E
• Device Catalogue Number: 900PT560E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P PT100 MYAIRVO 2 HUMIDIFIER.; F&P PT100 MYAIRVO 2 HUMIDIFIER.
• Patient Outcome(s): Other
• Patient Age: 15 MO