MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO 2 HEATED BREATHING TUBE; BTT

Model Number	900PT560
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in (b)(4) reported that five 900pt560 heated breathing tubes had melted.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving the subject 900pt560 heated breathing tubes for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in michigan reported that five 900pt560 myairvo 2 heated breathing tubes had melted.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).The heated breathing tube (hbt) is a component designed for use with the myairvo 2 humidifier (myairvo 2), for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The hbt as part of the myairvo 2 system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimizing the amount of condensate in the tube.Method: the customer stated that the 900pt560 myairvo 2 hbts were not available to be returned for evaluation.However, one 900pt560 myairvo 2 hbt was returned to fisher & paykel healthcare (f&p) for investigation where it was visually inspected and resistance tested.Our investigation is based on the evaluation of the returned hbt, the information provided by the healthcare facility and f&p's knowledge of the product.Results: the visual inspection revealed that the returned hbt was still sealed in its original packaging and no indication of melting was observed.Testing revealed the hbt was functioning as intended.The customer stated that five hbts had melted.The customer further reported that the circuit clip was not used to secure the hbts in place.Conclusion: we are unable to determine the cause of the reported event as there was no fault found with the returned hbt.However, damage to the hbt may be caused by factors such as incorrect set-up or covering it with a material or object for a prolonged period.The nature of the damage observed in the returned hbt suggests that the hbt was covered by a material or object for a prolonged period of time.Parts of the hbt were also observed to have softened and started to unravel, which is consistent with tube being covered and then being subjected to tension or excessive force.The 900pt560 user instructions show in pictorial format the correct placement of the device and includes the following information: "connect breathing tube clip to patient clothing or bedding." "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, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." all hbts as part of the 900pt560 myairvo 2 heated breathing tubes are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The heated breathing tubes are 100% visually inspected using a camera system.The hbts are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The hbt would have met the required specifications at the time of production.

• Brand Name: MYAIRVO 2 HEATED BREATHING TUBE
• Common Device Name: 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14005015
• Report Number: 9611451-2022-00337
• Device Sequence Number: 2265218
• Product Code: BTT
• UDI-Device Identifier: 09420012448040
• UDI-Public: (01)09420012448040(10)2101545740(11)210310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 900PT560
• Device Catalogue Number: 900PT560
• Device Lot Number: 2101545740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown