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

Model Number PT101

Device Problem Power Problem (3010)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/10/2023

Event Type  Injury  

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare field representative that a pt101 airvo 2 humidifier display became dark and the flow had ceased during use.It was reported that the patient desaturated from the 70% range of spo2 to the 30% range of spo2 at the time of the event.The device was restarted, and the patient recovered to the 70% range of spo2.It was also reported by the healthcare facility that the patient had covid-19 and was in a poor condition prior to the event.The healthcare facility further reported that the patient passed away approximately 13 hours after the reported event and that they don't consider the reported event to be the direct cause of death.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Manufacturer Narrative

(b)(4).Corrected data: g1 updated.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the subject airvo 2 was received at fisher & paykel healthcare (f&p) in new zealand where it was inspected, and performance tested by a trained f&p technician.Our investigation is based on the information provided by the customer, our evaluation of the subject device and our knowledge of the product.Results: the healthcare facility reported that the display had become dark and the flow had ceased on the subject airvo 2 during use on the patient.It was also reported that the patient, who had covid-19 and was in a poor condition, had desaturated from 70% spo2 to 30% spo2 at the time of the event.The subject device was restarted, and the patient recovered to 70% spo2.Visual inspection of the returned device revealed no signs of damage to the device.The device was powered on and the device's display, audible alarm and oxygen sensor were found to be operating as expected.A review of the device log showed no recorded faults.The device was tested by running for eight hours with no fault found.The device was opened for further investigation and all internal components were found to be in good condition.Conclusion: we are unable to determine the cause of the reported event, as there was no fault found with the returned device.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification.These quality control measures are performed at the end of the final assembly process on 100% of the manufactured units.Any unit that fails any of these tests will be rejected.The subject device has met the required specifications.The following specific controls ensure each device delivers flow as per the device performance specifications and that the unit is free from any physical damage: visual examination: each unit is visually inspected for external damage and rejected if any damage is identified.Pressure flow testing: each unit is pressure tested to ensure there are no leaks in the airpath.Flow and oxygen sensors are calibrated and checked for accuracy.Soak and reliability testing: each unit is connected to a hbt and water chamber, and then tested to ensure it performs as intended over extended operating conditions.The airvo 2 user instructions state the following: "the unit is not intended for life support." "appropriate patient monitoring must be used at all times.Loss of power means loss of therapy." "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." "never operate the unit if it is not working properly." the healthcare facility reported that the patient was in poor condition prior to the event.Despite recovering to the 70% range of spo2, the patient passed away approximately 13 hours after the reported event.The healthcare facility stated they do not consider the reported event to be the direct cause of death.

Event Description

On 10 february 2023 a distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare field representative that on 10 february 2023 a pt101 airvo 2 humidifier display became dark and the flow had ceased.It was also reported that the patient desaturated from the 70% range of spo2 to the 30% range spo2 at the time of the event.The device was restarted, and the patient recovered to the 70% range of spo2.The healthcare facility also reported that the patient had covid-19 and was in a poor condition prior to the event.The healthcare facility also reported on (b)(6) 2023 that the patient passed away approximately 13 hours after the reported event and that they don't consider the reported event to be the direct cause of death.

• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16514125
• MDR Text Key: 310989878
• Report Number: 9611451-2023-00169
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422323
• UDI-Public: (01)09420012422323(10)2101676700(11)210615
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101676700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female