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

Model Number 900PT561

Device Problem Melted (1385)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

A healthcare facility in china reported that the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted during use.The device was immediately replaced.The healthcare facility reported that patient's spo2 levels were 98% prior the event.Then the patient desaturated between spo2 of 92% and 94%.But the device was replaced and the patient's spo2 increased.No further patient consequences were reported.The healthcare facility also reported that the subject hbt device was set up with a non-f&p high flow device, and the subject hbt device was attached to the pillow.

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 china reported that the heated breathing tube (hbt) as part of the 900pt561 heated breathing tube and chamber kit was found melted during use.The device was immediately replaced.The healthcare facility reported that patient's spo2 levels were 98% prior the event.Then the patient desaturated between spo2 of 92% and 94%.But the device was replaced and the patient's spo2 increased.No further patient consequences were reported.The healthcare facility also reported that the subject hbt device was set up with a non-f&p high flow device, and the subject hbt device was attached to a pillow.

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.Our investigation is based on the photographs and description of events provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photographs revealed that the hbt was melted, exposing the heater wires.The photographs provided by the healthcare facility also revealed that the hbt was believed to have been partially covered by the pillow.The healthcare facility reported that the subject hbt device was set up with a non-f&p high flow device.The healthcare facility also reported that patient's spo2 levels were 98% prior the event.Then the patient desaturated between spo2 of 92% and 94%.But the device was replaced and the patient's spo2 increased.No further patient consequences were reported.Conclusion: we are unable to determine the exact cause of the reported event.However, the damage to the heated breathing tube was likely caused by it being partially covered by a pillow for a prolonged period.The 900pt561 user instructions 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 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." 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 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 900pt561 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.However, it was reported by the healthcare facility that the subject hbt device was set up with a non-f&p high flow device.

• Brand Name: AIRSPIRAL TUBE AND AUTO-FILL 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: 18813621
• MDR Text Key: 336743679
• Report Number: 9611451-2024-00168
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2102118976(11)220401
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 2102118976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• 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