MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER; HEATED BREATHING TUBE

Model Number 900PT562

Device Problems Melted (1385); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The f&p (b)(6) airvo tube and chamber kit with nebulizer is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The complaint device is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the united kingdom reported that the heated breathing tube as part of a (b)(4) airvo tube and chamber kit with nebulizer adapter was found melted onto the mattress and pillow.It was reported that the patient was lying on top of the heated breathing tube.There was no reported patient consequence.

Event Description

A healthcare facility in the united kingdom reported that the heated breathing tube as part of a 900pt562 airvo tube and chamber kit with nebulizer adapter was found melted onto the mattress and pillow.It was reported that the patient was lying on top of the heated breathing tube.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo tube and chamber kit with nebulizer is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k162553.Method: the complaint heated breathing tube as part of the 900pt562 airvo tube and chamber kit with nebulizer adapter was returned to fisher & paykel healthcare (f&p) for evaluation.Results: visual inspection of information received from the customer revealed that the heated breathing tube had melted.The customer further reported that the patient was lying on top of the heated breathing tube.Conclusion: damage to the heated breathing tube was caused by it being covered by the patient.All heated breathing tubes as part of the 900pt562 airvo tube and chamber kits with nebulizer adapters are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.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.Additionally, a functional test is conducted under load.The subject heated breathing tube would have met the required specifications at the time of production.The airvo 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 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 continuously checks power in the heated breathing tube and disables the heater wire if the measured power is too high.The airvo 2 humidifier user manual provides instructions for cleaning and maintenance including daily and weekly cleaning, followed by schedule for changing accessories, it also states: - 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.- use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.- "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" - "the unit is not intended for life support." - "appropriate patient monitoring must be used at all times." the 900pt562 user instructions includes the following, cautions and warnings: - "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 allow the breathing tube to remain in direct contact with skin for prolonged periods of time.".

• Brand Name: AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 12840156
• MDR Text Key: 284638355
• Report Number: 9611451-2021-01303
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT562
• Device Catalogue Number: 900PT562
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• 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