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

Model Number 900PT561

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The healthcare facility reported that they have discarded the subject device.Fisher & paykel healthcare (f&p) has requested further information about the reported event and patient condition.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.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 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, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." - "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.".

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative that a heated breathing tube as part of the 900pt561 heated breathing tube and chamber kit was found melted during use.It was also reported by the healthcare facility that the patient, who was not wearing a shirt and lying on the heated breathing tube, received a burn in their armpit at the time of the event.There were no further patient consequences reported.

Event Description

A healthcare facility in (b)(6) 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 during use.It was further reported by the healthcare facility that the patient who was not wearing a shirt and had been laying with the hbt in their armpit for an estimated four hours had received a burn three inches long and two inches wide in their armpit at the time of the event.The healthcare facility reported that the burn was dressed appropriately and there were no further patient consequences reported.

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.The healthcare facility reported that they have discarded the subject device and could not provide photos of the device or patient injury.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility has stated that the subject hbt had melted during use on a patient who was not wearing a shirt and had been laying with the hbt in their armpit for an estimated four hours.It was also reported by the healthcare facility that the patient had received a burn three inches long and two inches wide in their armpit at the time of the event.The healthcare facility reported that the burn was dressed appropriately and there were no further patient consequences reported.Conclusion: the patient injury and damage to the hbt was caused by it being placed in the patient armpit for a prolonged period of time.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 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, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." - "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 is 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: 17484111
• MDR Text Key: 321154583
• Report Number: 9611451-2023-00730
• 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: 07/10/2023

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: 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
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/04/2023
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Age: 6 YR