MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems No Audible Alarm (1019); Moisture or Humidity Problem (2986); Misassembled During Installation (4049)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information and the return of the subject pt101 airvo 2 humidifier for investigation.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 patient desaturated to 50% spo2 whilst using a pt101 airvo 2 humidifier and an optiflow adult nasal cannula.The healthcare facility further reported that the patient's family noted "some condensation" in the optiflow adult nasal cannula.To manage the condensation, the cannula was replaced and it was noted that the water chamber had not been inserted correctly.Once the water chamber was further inserted into the complaint airvo 2 humidifier, the patient recovered to a stable condition, with no further patient consequences.It was further noted that the complaint airvo 2 humidifier had no audio alarm.

Event Description

A healthcare facility in the netherlands reported, via a fisher & paykel healthcare (f&p) field representative, that a patient desaturated to 50% spo2 whilst using a pt101 airvo 2 humidifier and an optiflow adult nasal cannula.The healthcare facility further reported that the patient's family noted "some condensation" in the optiflow adult nasal cannula.To manage the condensation, the cannula was replaced and it was noted that the water chamber had not been inserted correctly.Once the water chamber was further inserted into the complaint airvo 2 humidifier, the patient recovered to a stable condition, with no further patient consequences.It was further noted that the complaint airvo 2 humidifier had no audio alarm.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 humidifier was received at fisher & paykel healthcare (f&p) in new zealand.Our investigation is based on an evaluation of the subject device as well as the information provided by the customer.The device was performance tested and the audible alarm function was checked.Results: the customer reported that the 900pt290e autofeed chamber had not been inserted correctly.Visual inspection of the subject pt101 airvo 2 humidifier revealed no issues with the chamber soft coupling that would prevent the chamber from fitting.During testing it was found that the audible alarm did not function.Previous investigations into this type of failure have identified that the problem is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to be open circuit.Conclusion: it was concluded that the reported event occurred due to incorrectly inserting the chamber.F&p noted that training on the pt101 airvo 2 humidifier and optiflow adult nasal cannula was provided prior to the reported event.Further training since the reported event has also been offered.As part of our ongoing product improvement initiatives, a new speaker unit for the pt101 airvo 2 humidifier has been sourced from a different supplier.The airvo 2 humidifier user manual states: - "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." - "fit the water chamber to the unit by pressing down the finger guard and sliding the chamber on, carefully aligning with the blue chamber port ends.Push the chamber on firmly until the finger guard clicks into place." the user manual warns the user: - "appropriate patient monitoring must be used at all times." - "do not start the unit without the water chamber in place." - "prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section." the alarm system functionality check instructs the user on how to test the alarm and states that "if either alarm signal is absent, do not use the unit" and "contact your fisher & paykel healthcare representative.".

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 11792494
• MDR Text Key: 249549838
• Report Number: 9611451-2021-00515
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100062988(11)160712
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100062988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P 900PT290E AUTOFEED CHAMBER; F&P OPTIFLOW ADULT NASAL CANNULA; F&P OPTIFLOW ADULT NASAL CANNULA; F&P OPTIFLOW ADULT NASAL CANNULA
• Patient Outcome(s): Other
• Patient Age: 67 YR