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

Model Number 900PT561

Device Problem Melted (1385)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel (f&p) field representative that a 900pt561 airvo heated breathing tube used with an airvo2 humidifier was found melted under a pillow.The patient oxygen saturation decreased.No further patient consequences was reported.

Manufacturer Narrative

(b)(4).Method: the complaint 900pt561 airvo heated breathing tube was returned to fisher & paykel healthcare (f&p) for investigation where it was visually inspected.Result: a visual inspection of the subject 900pt561 tube revealed that the breathing tube had partially unraveled and was damage.The damage was the melting of the plastic resulting in the heater wire being exposed.It was noted that part of the tube was flattened indicating that it may have been covered at some point.The heater wire insulation was not intact to enable resistance testing.The customer reported that the subject 900pt561 heated breathing tube was covered under the pillow.Conclusion: damage to the heated breathing tube may be caused by covering it with a material and /or being under compressive load for a considerable length of time.The reported damage to the heated breathing tube was likely caused by the tube being covered by a pillow and under a compressive load.All heated breathing tubes as part of the 900pt561 heated breathing tube and chamber kits are visually inspected and undergo functional tests, including soak, 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.Before the product leaves the line, a full 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 constantly checking power in the heated breathing tube and turns the heater wire off if the measured power is too high.The 900pt561 user instructions includes the following warning: - do not add heat to any part of the breathing tube e.G., covering with a blanket as this could result in serious injury.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.- use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.- airvo 2/ 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.

Event Description

A healthcare facility in the uk reported via a fisher & paykel (f&p) field representative that a 900pt561 airvo heated breathing tube used with an airvo2 humidifier was found melted under a pillow.The patient oxygen saturation decreased to 89% and was connected on a 15l oxygen via non-rebreather face mask while the 900pt561 airvo heated breathing tube was replaced.The patient oxygen saturation recovered.No further patient consequences was reported.

• Brand Name: HEATED BREATHING TUBE
• Type of Device: AIRVO 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 ; 9494534000
• MDR Report Key: 12375694
• MDR Text Key: 280948629
• Report Number: 9611451-2021-00998
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 11/09/2021
• 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 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER