MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER; BTT

Model Number 900PT562

Device Problems Melted (1385); Smoking (1585); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the heated breathing tube of a 900pt562 airvo2 tube and chamber kit with nebulizer adapter was compressed between a pillow and the mattress (by the body weight of the patient).The 900pt562 airvo tube and chamber kit was set up with a pt101 airvo 2 humidifier which was reported to have been alarming for 5 minutes at the time of the incident.A nurse noticed some smoke coming from the pillow and removed the patient from the bed.There was no patient consequence.

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo2 tube and chamber kit with nebulizer adapter 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.Further information about the reported event and the subject 900pt562 airvo tube and chamber kit with nebulizer adapter and pt101 airvo 2 humidifier have been requested to be returned for evaluation.We will provide a follow-up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo2 tube and chamber kit with nebulizer adapter 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.Further information about the reported event and the subject 900pt562 airvo tube and chamber kit with nebulizer adapter and pt101 airvo 2 humidifier have been requested to be returned 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 healthcare (f&p) field representative that the heated breathing tube of a 900pt562 airvo2 tube and chamber kit with nebulizer adapter was compressed between a pillow and the mattress (by the body weight of the patient).The 900pt562 airvo tube and chamber kit was set up with a pt101 airvo 2 humidifier which was reported to have been alarming for 5 minutes at the time of the incident.A nurse noticed some smoke coming from the pillow and removed the patient from the bed.There was no patient consequence.

Manufacturer Narrative

(b)(4).The f&p 900pt562 airvo2 tube and chamber kit with nebulizer adapter 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 (hbt), pt101 airvo 2 humidifier (airvo 2) and the opt942 optiflow + adult nasal cannula were returned to fisher & paykel healthcare (f&p) for investigation.Additionally, the mattress cover, pillow, pillow cover and a section of the mattress were received for investigation.Our investigation is based on the evaluation of the airvo 2 device and accessories, visual inspection of the items received, assessment of the information provided by the healthcare facility and our knowledge of our products.Results: visual inspection of the returned 900pt562 hbt revealed that the hbt was separated in two main pieces which had sections that were damaged.A third piece of the hbt was identified in the mattress.All pieces of the hbt were measured and the length of the parts did not add up to the complete 900pt562 tube length.The two main parts of the tube were observed to be clean with no signs of smoke damage or staining.It was noted that a piece of the pillow was stuck to the tube where it had melted.The healthcare facility reported that the complaint 900pt562 hbt was compressed between a pillow and the mattress by the body weight of the patient.They also noted that the hbt included the alert tag warning which states that the hbt should not be covered.The healthcare facility further reported that the airvo 2 was alarming for five minutes at the time of the reported event.The hbt contains a heater wire which ensures optimal temperature and humidification levels are delivered to the patient.Damage to the hbt can occur if it is covered by a material and/or under a compressive load for an extended period of time.The mattress cover, pillow, pillow cover and a section of the mattress received from the healthcare facility were visually inspected and damaged areas were observed, consistent with the hbt being compressed between the mattress and pillow.The healthcare facility reported that the pillows and mattresses used at the hospital are made of fire-retardant materials.The healthcare facility has since provided further feedback to its staff on the correct use and placement of hbts, emphasizing that they should not be covered.The opt942 optiflow + adult nasal cannula was visually inspected and was found to be in good condition.The healthcare facility reported that there were no issues with the subject opt942; and that the blue clothing clip was not used.The airvo 2 was visually inspected and showed no signs of external damage.The device underwent performance and electrical testing and was run for an extended period of time.No error codes were observed, no faults were identified, and the device performed as expected.The device was opened for further investigation and no internal faults were found.The healthcare facility reported that the device has been in use for over five years.A review of the log revealed that on the day of the reported event an e146 error code was generated.When the temperature experienced at the patient end of the hbt is too high, the airvo 2 will switch off power to the hbt.The e146 error code is then triggered after one minute if the hbt continues to experience high temperatures.When an e146 error code is triggered, an audible alarm will sound, and visual alarm will display "fault e146" and "switch off the unit and then restart".Conclusion: there were no faults found with the airvo 2 or the opt942 devices that could have led to the reported event.Most of the complaint hbt was returned and based on the investigation findings and our knowledge of the product, the damage observed to the hbt was due to the hbt being covered with a pillow and placed under a compressive load for a considerable length of time.It was noted that the airvo 2 alarmed as expected, indicating that the patient end of the hbt was experiencing higher than expected temperatures.The manufacturing process of airvo 2 heated breathing tubes ensures safety by design.The entire airvo 2 system, including the heated breathing tube, is designed to comply with the electrical safety standard iec 60601-1: 2005+a1:2012.The surface temperature of the heated breathing tube is within the limits specified by iso 8185 with regard to hot tube surface temperature when used in accordance with user instructions.Furthermore, the airvo 2 case is composed of a flame retardant material.All hbts are visually inspected using a camera system.The hbt is also tested for resistance, continuity, polarity and pitch during production.Additionally, a full functional test is conducted under load for every hbt manufactured.The subject heated breathing tube would have met the required specifications at the time of production.There are many safety features incorporated into the airvo 2 system to prevent overheating and fire.These include: the heater wires in the heated breathing tube are completely insulated from the gas path.The pcb at the [patient] end of the hbt is over moulded with a thermoplastic polymer, ensuring it is excluded from the gas path.The airvo 2 device contains technology which detects any short circuit in the system.This functionality is checked by the control system when the airvo 2 is powering up before each use.Temperature sensors will automatically cut power to the heater plate and heater wire if overheating in the hbt is detected.The airvo 2 is continuously checking power in the heated breathing tube and disables the heater wire if the measured power is too high.Additionally, 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.Additionally, the hbt includes an alert tag to warn the user that the hbt should not be covered in any way.The 900pt562 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 add heat to any part of the breathing tube e.G., covering with a blanket as this could result in serious injury.

Event Description

A healthcare facility in the netherlands reported via a fisher & paykel healthcare (f&p) field representative that the heated breathing tube of a 900pt562 airvo tube and chamber kit with nebulizer adapter was compressed between a pillow and the mattress (by the body weight of the patient).The 900pt562 airvo tube and chamber kit was set up with a pt101 airvo 2 humidifier which was reported to have been alarming for 5 minutes at the time of the incident.A nurse noticed some smoke coming from the pillow and removed the patient from the bed.There was no patient consequence.

• Brand Name: AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
• 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: 13286104
• MDR Text Key: 286235426
• Report Number: 9611451-2022-00061
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: SEE H10
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• 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 OPT942 OPTIFLOW + ADULT NASAL CANNULA; F&P OPT942 OPTIFLOW + ADULT NASAL CANNULA; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER; WALL OXYGEN
• Patient Sex: Male