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

Model Number 900PT560E

Device Problem Melted (1385)

Patient Problem Cough (4457)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

A distributor in utah reported via a fisher and paykel healthcare (f&p) field representative that a section of the 900pt560e myairvo airspiral tube had been in contact with a patients blanket and had melted during use.It was also reported that the patient had developed a cough since the event.Fisher & paykel has requested for further information about the reported event including patient outcome.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) had requested for further information about the reported event, including patient outcome.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.

Event Description

On 15 february 2023 a homecare provider in utah reported via a fisher and paykel healthcare (f&p) field representative that a section of the 900pt560e myairvo airspiral tube had been in contact with a patients blanket and had melted during use.It was also reported that the patient had developed a cough since the event.The homecare provider reported that the patient visited the doctor following the event and was told to monitor the cough.An fda medwatch report (mw5117504) for the same event was received on 20 may 2023.Further information from the homecare provider reported that the patient had since recovered and that there were no patient consequences from the event.

Manufacturer Narrative

(b)(4).Product background: the 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 high flow therapy.High flow 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 received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was resistance tested and visually inspected.The homecare provider also provided additional information relating to the reported event upon request.Our investigation is based on the evaluation of the subject hbt, the information provided by the customer and our knowledge of the product.Results: the homecare provider reported that the hbt had melted onto the patient bedding.The patient was also reported to have developed a cough, however further information received from the homecare provider stated that patient recovered and there were no patient consequences.The visual inspection revealed that a section at the centre of the hbt was melted and a small section of the hbt at the user end had also unravelled.The "do not cover" tag was attached to the complaint hbt.The resistance checks on the heater wire were within specification.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and the observation that the hbt had melted onto the bedding, the reported damage to the hbt may have been caused by factors such as incorrect set-up or covering it with a material or object for a prolonged period.The myairspiral user instructions show in pictorial format the correct placement of the device and includes the following information: - "do not add heat to any part of the breathing tube e.G., covering with a blanket" - "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" - "connect breathing tube clip to patient clothing or bedding." - "do not block the flow of air through the unit and breathing tube." - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." all hbt 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 hbt are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The subject hbt would have met the required specifications at the time of production.The myairvo 2 system is designed to comply with the electrical safety standard iec 60601-1: 2005+a1:2012.The case is composed of a flame retardant material.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.It is an inherent risk of hbt, that additional heat (above ambient levels) added to any part of the tube via an external source or being covered with material, may lead to the tubing becoming damaged.To address this inherent risk and as is required under iso 80601, the user instructions for the myairspiral 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 tube 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 the 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 the hbt.- the myairvo 2 device is continuously checks power in the hbt and disables the heater wire if the measured power is too high.

• Brand Name: MYAIRVO AIRSPIRAL TUBE
• Type of Device: HEATED BREATHING TUBE
• 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 92618-2306 ; 8007923912
• MDR Report Key: 16560613
• MDR Text Key: 311510872
• Report Number: 9611451-2023-00194
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900PT560E
• Device Catalogue Number: 900PT560E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 6 YR
• Patient Sex: Female