MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject pt101 airvo 2 humidifier.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 pt101 airvo 2 humidifier shut down following a power outage at the hospital and a covid-19 patient desaturated.The patient was placed on bilevel positive airway pressure (bipap), recovered, and recommenced therapy with the subject pt101 airvo 2 humidifier as it was noted to be working.The patient was subsequently placed on another device.It was further reported that the patient was moved to the intensive care unit (icu) and passed away later that evening.Further information has been requested regarding the reported event, including the medical cause of death.

Event Description

A healthcare facility in kentucky reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier shut down following a power outage at the hospital and a covid-19 patient desaturated.The patient was placed on bilevel positive airway pressure (bipap), recovered, and recommenced therapy with the subject pt101 airvo 2 humidifier.The patient was subsequently placed on another device.It was further reported that the patient was moved to the intensive care unit (icu) and passed away later that evening.Further information was requested regarding the reported event, including the medical cause of death.

Manufacturer Narrative

Ps381941, method: the subject pt101 airvo 2 humidifier was returned to the fisher & paykel healthcare (f&p) regional facility in the united states of america, where it was visually inspected and performance tested.F&p contacted the customer to obtain further information regarding the reported event, including the medical cause of death; however, limited information was provided.Our investigation is based on the information provided by the customer and the inspection conducted at our regional facility.Results: visual inspection of the returned subject pt101 airvo 2 humidifier revealed no signs of external or impact damage.The unit was powered on and performance tested and was found to be working correctly, including the audible alarm and power out alarm.It was further reported that over 10 minutes after the power outage, the respiratory therapist went into the patient's room and discovered that the pt101 airvo 2 humidifier had shut down.It was noted that the patient had been using the device for nine days prior to the reported event.Conclusion: there was no fault found with the subject pt101 aivor 2 humidifier.The patient incident occurred following a power outage at the hospital which disrupted the power source of the device.The airvo 2 user manual states that "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases." the user manual also warns the user: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.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.If the unit has been disconnected from the mains/utility power socket, the auditory alarm will sound for at least 120 seconds.Use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.The subject pt101 airvo 2 humidifier was returned to the customer after passing all performance checks.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• 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: 12801183
• MDR Text Key: 280681375
• Report Number: 9611451-2021-01260
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2101457625(11)210112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101457625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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 CANNULA; F&P CANNULA; F&P CIRCUIT KIT; F&P CIRCUIT KIT; OXYGEN CONNECTED TO FLOWMETER; OXYGEN CONNECTED TO FLOWMETER
• Patient Outcome(s): Required Intervention; Other