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

Model Number 900PT500E

Device Problems Melted (1385); Ambient Temperature Problem (2878)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900pt500e heated breathing tube is currently en route to fisher & paykel healthcare (f&p) in (b)(4).We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a 900pt500e heated breathing tube used with a myairvo2 humidifier was found melted during use, underneath the patient's pillow.There was no patient consequence.

Event Description

A healthcare facility in michigan reported, via a fisher & paykel healthcare (f&p) field representative, that a 900pt500e heated breathing tube used with a myairvo2 humidifier was found melted during use, underneath the patient's pillow.Additional information was provided, that the patient's sister had ran the tubing under the patient's pillow.There was no patient consequence.

Manufacturer Narrative

Ps307719 the complaint (b)(4) heated breathing tube was returned to fisher & paykel healthcare (f&p) for investigation and was visually inspected and resistance tested.Result: a visual inspection of the subject 900pt500e tube revealed that the plastic of tube was melted exposing the heater wires.It was also noted that the in the affected area the tubing was also flattened.Conclusion: based on our observations of previous damaged heated breathing tubes, the information provided by the customer, as well as the results of this investigation, the tube was very likely covered by material with a temperature greater than that of typical room conditions and is possible to have been under compressive load for a considerable length 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 breathing tube.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 instruction that accompany the 900pt500e state the following: - do not cover the circuit with materials such as blankets.Towels, or bed linen or place in the path of radiant heat.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.".

• Brand Name: MYAIRVO BREATHING TUBE
• Type of Device: MYAIRVO HEATED BREATHING TUBE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8593581
• MDR Text Key: 144839179
• Report Number: 9611451-2019-00462
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900PT500E
• Device Catalogue Number: 900PT500E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PT100 MYAIRVO HUMIDIFIER; PT100 MYAIRVO HUMIDIFIER