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

Model Number 900PT560E

Device Problem Melted (1385)

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

Event Type  malfunction  

Event Description

A distributor in (b)(4) reported that a 900pt560e heated breathing tube had melted.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The complaint 900pt560e heated breathing tube is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).The complaint 900pt560e heated breathing tube is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor in (b)(4) reported that a 900pt560e heated breathing tube had melted.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint 900pt560e heated breathing tube was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Result: the customer reported that a 900pt560e heated breathing tube had melted.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.However, damage to the heated breathing tube may be caused by factors such as incorrect set-up, subjecting it to excessive force, inappropriate cleaning, covering it with a material and /or being under compressive load for a considerable length of time.All 900pt560e heated breathing tubes 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 myairvo 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.- "myairvo 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 900pt560e heated breathing tube user instructions show in pictorial format the correct placement of the device and includes the following information: - "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 soak, wash or sterilize." - "avoid contact with chemicals, cleaning agents, or hand sanitizers" - "this product is not intended for use with any medication." - "do not add heat to any part of the breathing tube e.G., covering with a blanket as this could result in serious injury." - "this product is intended to be used for a maximum of 60 days for home use, provided that the myairvo 2 cleaning and maintenance instructions are followed.".

Event Description

A distributor in canada reported on behalf of a consumer that a 900pt560e heated breathing tube had melted.There was no reported patient consequence.

• Brand Name: HEATED BREATHING TUBE
• Type of Device: BTT
• 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: 13256672
• MDR Text Key: 286249867
• Report Number: 9611451-2022-00040
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012448040
• UDI-Public: (01)09420012448040(10)2100854850(11)190816
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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: Lay User/Patient
• Device Model Number: 900PT560E
• Device Catalogue Number: 900PT560
• Device Lot Number: 2100854850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 02/20/2022
• Supplement Dates FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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 PT100 MYAIRVO 2 HUMIDIFIER; F&P PT100 MYAIRVO 2 HUMIDIFIER