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

Model Number PT101

Device Problems Use of Device Problem (1670); Complete Loss of Power (4015)

Patient Problems Respiratory Arrest (4461); Insufficient Information (4580)

Event Date 08/13/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event including the medical cause of death and the full sequence of events.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.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Additionally, 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.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a 93 year old patient, who had just undergone an emergency laparotomy surgery and had a poor prognosis, arrested on arrival at the intensive treatment unit (itu) following a transfer from the recovery unit.It was reported that the patient later deceased.At the time of transfer, the patient was connected to a pt101 airvo 2 humidifier (airvo 2).The healthcare facility further reported, that during the transfer, the airvo 2 was not plugged into a power source.There was no allegation of malfunction with the subject airvo 2.Further information has been requested from the healthcare facility regarding the reported event, including the medical cause of death and the full sequence of events.

Manufacturer Narrative

(b)(4).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 complaint airvo 2 was not returned to fisher & paykel healthcare (f&p) for evaluation.Further information regarding the reported event, including the medical cause of death and the full sequence of events was requested from the healthcare facility.However, limited information was provided.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the airvo 2 was used without a power source during patient transfer.The healthcare facility did not report any fault with the airvo 2.It was further reported that the patient arrested and at least one round of cpr was provided, the patient subsequently passed away.The patient was reported to be in poor condition prior to the event.Conclusion: without a power source the airvo 2 will not provide therapy to the patient.The airvo 2 will provide an audible alarm for at least 120 seconds when the device is disconnected from a power source.Additional airvo 2 training was provided to the healthcare facility by a f&p field representative.The pt101 airvo 2 humidifier user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." additionally, 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.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a (b)(6) patient, who had just undergone an emergency laparotomy surgery and had a poor prognosis, arrested on arrival at the intensive treatment unit (itu) following a transfer from the recovery unit.It was reported that the patient later deceased.At the time of transfer, the patient was connected to a (b)(6) airvo 2 humidifier (airvo 2).The healthcare facility further reported, that during the transfer, the airvo 2 was not plugged into a power source.There was no allegation of malfunction with the subject airvo 2.Further information was requested from the healthcare facility regarding the reported event, including the medical cause of death and the full sequence of events.Limited information was provided.

• 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 ; 9494534002
• MDR Report Key: 15415371
• MDR Text Key: 299829718
• Report Number: 9611451-2022-00842
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 93 YR