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

Model Number 900PT531

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 900pt531 junior heated breathing tube (hbt) is used with the airvo humidifier to deliver warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Method: the complaint 900pt531 hbt was not returned to fisher & paykel healthcare for evaluation.Our investigation is therefore based on our knowledge of the product, information and photographs provided by the customer and previous similar investigations.Results: without the complaint device it is not possible to conclusively determine what caused the reported failure.However, visual inspection of the photographs revealed some deformation in a small section in the centre of the tubing.The tubing had softened and deformed slightly in this section of the limb and small holes had formed.Conclusion: the observed damage is consistent with the tubing having been covered with bedding or similar for a lengthy period of time.The heater wires are coated with teflon, which remains intact even under compressive load and has a much higher melting point than the hbt.During production the heater wires are 100% visually inspected using a camera system.The heater wires are also tested for resistance, continuity, polarity and pitch during production.Before the product leaves the line a full functional test is conducted under load.The airvo system is designed to comply with the electrical safety standard ul60601-1.The case is composed of a flame retardant material.The surface temperature of the heated breathing tube is within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.There are many safety features incorporated into the airvo to prevent overheating and fire.These include: the heater wires in the heated breathing tube are coated with teflon, completely insulating them from the gas path.The pcb at the [patient] end of hose is over moulded with the thermoplastic polymer polypropylene, ensuring it is excluded from the gas path.The airvo contains a transient current detector, tcd.This tcd is tested on the production line.It is also checked by the control system when the airvo is powering up before each use.An 'over-temperature' sensor will automatically cut power to the motor, heater plate and heater wire if it detects any overheating.The airvo is constantly checking power in the heated breathing tube and turns the heater wire off if the measured power is too high.The user instructions that accompany the airvo 2 humidifier include the following warning: adding heat, above ambient levels, to any part of the breathing tube or interface, e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, could result in serious injury.The user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.

Event Description

A hospital in (b)(6) reported via a fisher & paykel (f&p) representative that a 900pt531 airvo junior heated breathing tube used with an airvo2 humidifier was found melted.No patient consequence was reported.

• Brand Name: HEATED BREATHING TUBE
• Type of Device: AIRVO 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8458755
• MDR Text Key: 140152182
• Report Number: 9611451-2019-00271
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT531
• Device Catalogue Number: 900PT531
• Device Lot Number: 140701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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 900PT290 HUMIDIFICATION CHAMBER; F&P OPT316 OPTIFLOW JUNIOR NASAL CANNULA