MAUDE Adverse Event Report: HEATED BREATHING TUBE; AIRVO HEATED BREATHING TUBE

Model Number 900PT561

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900pt561 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 our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a airvo heated breathing tube was melted on the bed.There was no patient consequence.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a airvo heated breathing tube was melted on the bed.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the (b)(4) airvo heated breathing tube was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and resistance tested.Result: a visual inspection of the subject (b)(4) tube revealed that tube was melted.The heater wire insulation was observed to be intact and a resistance check on the heater wire was within specification.A visual inspection of the provided photographs by the customer revealed that the tube had partially melted onto the bed cover.Conclusion: we were unable to determine the cause of the reported event.Based on previous investigations of similar complaints, damage to the tube can be caused by it being covered by material with a temperature greater than that of typical room conditions and/or being under compressive load for a considerable length of time.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 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.".

• Brand Name: HEATED BREATHING TUBE
• Type of Device: AIRVO HEATED BREATHING TUBE
• MDR Report Key: 10550719
• MDR Text Key: 208538032
• Report Number: 9611451-2020-00795
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 AIRVO2 RESPIRATORY HUMIDIFIER; F&P PT101 AIRVO2 RESPIRATORY HUMIDIFIER