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

Model Number 900PT562

Device Problem Melted (1385)

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

Event Date 09/08/2021

Event Type  malfunction  

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 a 900pt562 airvo tube and chamber kit with nebulizer was not returned to fisher & paykel healthcare (f&p) for investigation.Our investigation is based on the information and photographs provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Result: visual inspection of the photographs provided by the customer revealed that the tube was melted and some portions of the tube were flattened indicating a compressive load may have been applied on top of the tube.The customer further reported that the heated breathing tube was partially covered by a blanket.Conclusion: damage to the heated breathing tube was caused by it being partially covered with a blanket.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 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 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 the (b)(4) reported via a fisher & paykel (f&p) field representative that the heated breathing tube as part of a 900pt562 airvo tube and chamber kit with nebulizer used with a pt101 airvo 2 humidifier was found melted.It was further reported that the heated breathing tube was partially covered by a blanket.There was no patient consequence.

• Brand Name: AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER
• Type of Device: HEATED BREATHING TUBE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 12594484
• MDR Text Key: 275438200
• Report Number: 9611451-2021-01108
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/07/2021
• 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