MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HEATED BREATHING TUBE AND CHAMBER KIT

Model Number 900PT561

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

A healthcare facility in kentucky reported via a fisher and paykel healthcare (f&p) field representative that a heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted.The healthcare facility reported that the pt101 airvo 2 humidifier used with the hbt was powered off and that the patient interface and subject hbt were removed from the patient and placed on a chair while the patient completed physical therapy, the patient then sat down on the chair and once the patient moved it was found that the subject hbt had melted.It was also reported by the healthcare facility following the event the device was discarded.No patient consequence was reported, the patient was not receiving therapy via the subject hbt at the time of the reported 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 heated breathing tube (hbt) is a component designed for use with the airvo 2 humidifier (airvo 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 airvo 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 airvo 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

A healthcare facility in kentucky reported via a fisher and paykel healthcare (f&p) field representative that a heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted.The healthcare facility reported that the pt101 airvo 2 humidifier used with the hbt was powered off and that the patient interface and subject hbt were removed from the patient and placed on a chair while the patient completed physical therapy, the patient then sat down on the chair and once the patient moved it was found that the subject hbt had melted.It was also reported by the healthcare facility that following the event the subject device was discarded.No patient consequence was reported, the patient was not receiving therapy via the subject hbt at the time of the reported event.

Manufacturer Narrative

(b)(4).Product background: the heated breathing tube (hbt) is a component designed for use with the airvo 2 humidifier (airvo 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 airvo 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 airvo 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 as part of the 900pt561 heated breathing tube and chamber kit was not returned to fisher & paykel healthcare (f&p) for evaluation as the healthcare facility discarded the device.Further information about the reported event including the device settings, if there were any external heating sources, and confirmation that the subject hbt has been sat on by the patient was requested from the healthcare facility on several occasions, however no additional information was provided.Our investigation is thus based on the limited information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the subject hbt was removed from the patient and then placed on a chair which was then sat on by the patient and that when the patient moved the hbt was found melted.It was also reported that the airvo 2 used with the hbt had been powered off at the time of the event.Conclusion: without the subject device or further information about the reported event, we are unable to determine the cause of the reported event.However, damage to the hbt may be caused by factors such as incorrect set-up or covering it with a material or object for a prolonged period.The 900pt561 heated breathing tube and chamber kit 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, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." - "connect breathing tube clip to patient clothing or bedding." - "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" - "do not block the flow of air through the unit and breathing tube." all hbts as part of the 900pt561 heated breathing tube and chamber kit 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 hbts are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The hbt would have met the required specifications at the time of production.The airvo 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 hbts, 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 900pt561 heated breathing tube and chamber kit contains the warning "do not add heat to any part of the breathing tube e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." additional "do not cover" tags are also attached to all hbts to alert the user that the hbt should not be covered.There are many safety features incorporated into the airvo 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 airvo 2 device contains technology which detects short circuits and transient current events in the hbt.When detected, the airvo removes power to the hbt.The airvo 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 airvo 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 airvo 2 device continuously checks power in the hbt and disables the heater wire if the measured power is too high.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• 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 ; 8007923912
• MDR Report Key: 18499917
• MDR Text Key: 332774687
• Report Number: 9611451-2024-00016
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER