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

Model Number 900PT561

Device Problem Melted (1385)

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

Event Date 10/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was recently received at fisher & paykel healthcare (f&p).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 the heated breathing tube as part of a 900pt561 airvo 2 heated breathing tube and chamber kit melted whilst placed underneath a pillow during use.It was further reported that the blue circuit clip was not used.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint heated breathing tube as part of the 900pt561 airvo heated breathing tube and chamber kit was returned to fisher & paykel healthcare (f&p) for investigation where it was visually inspected.Results: visual inspection of the heated breathing tube revealed that the heated breathing tube had melted, and the heater wire was exposed.The customer further reported that the subject heated breathing tube was placed underneath a pillow during use and that the blue circuit clip was not used.Conclusion: damage to the heated breathing tube was caused by it being covered by the pillow.All heated breathing tubes as part of the 900pt561 heated breathing tube and chamber kits 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 900pt561 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 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 airvo 2 cleaning and maintenance instructions are followed.".

Event Description

A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative that the heated breathing tube as part of a 900pt561 airvo 2 heated breathing tube and chamber kit melted whilst placed underneath a pillow during use.It was further reported that the blue circuit clip was not used.There was no patient consequence.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• 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: 12669625
• MDR Text Key: 280054977
• Report Number: 9611451-2021-01206
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2100751982(11)190416
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2100751982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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 PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Sex: Male