MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRSPIRAL TUBE AND AUTO-FILL CHAMBER KIT WITH NEBULISER ADAPTER; HEATED BREATHING TUBE

Model Number 900PT563

Device Problem Melted (1385)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

A healthcare facility in georgia reported via a fisher and paykel healthcare (f&p) field representative that the heated breathing tube as part of the 900pt563 airvo tube and chamber kit with nebuliser adapter was found melted during use.There were no patient consequences.

Manufacturer Narrative

(b)(4) 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 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.

Manufacturer Narrative

(b)(4) corrected data: a1,b5,d4,d9,g3,h3,h6 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 900pt563 airvo tube and chamber kit with nebuliser adapter was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was resistance tested and visually inspected.The healthcare facility also provided additional information relating to the reported event upon request.Our investigation is thus based on the evaluation of the subject hbt, the information provided by the healthcare facility and our knowledge of the product.Results: the resistance check on the heater wire was within specification.The visual inspection revealed that the subject hbt was melted in the middle of the tube and part of the tubing was stuck to the bedding sheet.The subject hbt tubing wire was also broken, confirming the event.The healthcare facility reported that the hbt was covered by a pillow that the patient was laying on.Conclusion: damage to the heated breathing tube was caused by it being covered by a pillow that the patient was laying on for a prolonged period.The 900pt563 user instructions state "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".The 900pt563 user instructions also show in pictorial format the correct placement of the device and includes the following information: - "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." - "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." - "if used with a nebulizer at any time, the 900pt563 kit must be disposed of after a maximum of 7 days' use, whether nebulization is continuous or intermittent during this time." all hbts as part of the 900pt563 heated breathing tube and chamber kit with nebulizer adapter 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 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 900pt563 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 is continuously checks power in the hbt and disables the heater wire if the measured power is too high.

Event Description

A healthcare facility in georgia via a fisher and paykel healthcare (f&p) field representative that the heated breathing tube as part of the 900pt563 airvo tube and chamber kit with nebuliser adapter was found melted during use.The healthcare further reported that the subject device was covered by a pillow that the patient was laying on.There were no patient consequences.

• Brand Name: AIRSPIRAL TUBE AND AUTO-FILL CHAMBER KIT WITH NEBULISER ADAPTER
• 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: 18585150
• MDR Text Key: 333825564
• Report Number: 9611451-2024-00053
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012463159
• UDI-Public: (01)09420012463159(10)2102714635(11)230731
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT563
• Device Catalogue Number: 900PT563
• Device Lot Number: 2102714635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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