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

Model Number 900PT501

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

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a 900pt501 adult heated breathing tube used with an airvo2 humidifier had melted while in use.The tube was under a pillow during patient's use.The patient desaturated.There was no further patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) heated breathing tube was not returned to fisher & paykel healthcare (f&p) for evalaution.Our investigation is based on the information and photograph provided by the customer, and our knowledge of the product.Result: a visual inspection of the photograph provided by the customer revealed that several areas of the tube were damaged and deformed.Conclusion: based on our observations of previous damaged heated breathing tubes, and the information provided by the customer, 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 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 healthcare facility in nebraska reported via a fisher & paykel healthcare (f&p) field representative that a 900pt501 adult heated breathing tube used with an airvo2 humidifier had melted while in use.The tube was under a pillow during patient's use.The patient desaturated.There was no further patient consequences.

• 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
• MDR Report Key: 9293298
• MDR Text Key: 178569534
• Report Number: 9611451-2019-01062
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT501
• Device Catalogue Number: 900PT501
• Device Lot Number: 2100688701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P AIRVO 2 HUMIDIFIER; F&P AIRVO 2 HUMIDIFIER