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

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Low Oxygen Saturation (2477); Insufficient Information (4580)

Event Date 02/16/2023

Event Type  Death  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested further information from the healthcare facility about the reported event including the medical cause of death and sequence of events.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.The user instructions which accompany the airvo 2 provide guidance for managing condensate and instruct the user that "if excess condensate accumulates in the heated breathing tube, disconnect the patient interface from the heated breathing tube, drain the condensate by lifting the patient end of the tube, allowing the condensate to run into the water chamber".

Event Description

A patient's spouse reported that the patient was in hospital receiving therapy via a pt101 airvo 2 humidifier (airvo 2).The patient spouse reported that there was an event where the subject airvo 2 had excessive condensation and that the tube used with the subject airvo 2 was disconnected.The patient's spouse also reported that the patient passed away the day after the reported event.Fisher & paykel healthcare (f&p) has requested further information from the hospital about the reported event including the medical cause of death and sequence of events.

Event Description

A patient's spouse reported on 11 december 2023 to fisher & paykel (f&p) healthcare that on (b)(6) 2023, the patient desaturated to 46% spo2 following physical therapy and that at the time the pt101 airvo 2 humidifier (airvo 2) in use had shut down and that the tube used with the subject airvo 2 had excessive condensation and was disconnected.It was also reported by the spouse that the patient saturation recovered to at least 72% following the event.The spouse reported that the patient passed away the day after the reported event.An fda medwatch report (mw5150620) submitted by the spouse for the same event was received by f&p healthcare on 29 jan 2024.The healthcare facility was contacted to get additional information on the reported event.The healthcare facility stated that the event did not relate to a fault.The healthcare facility was unable to provide the serial number of the airvo2 device in use at the time of the reported event.Additionally, they were unable to provide the model code of the circuit in use and confirmed that this had been discarded following patient use.Without return of the subject devices f&p healthcare is unable to confirm if a f&p healthcare device caused or contributed to the reported event or if a device malfunction occurred.

Manufacturer Narrative

(b)(4).The healthcare facility was contacted to get additional information on the reported event.The healthcare facility stated that the event did not relate to a fault.The healthcare facility was unable to provide the serial number of the airvo2 device in use at the time of the reported event.Additionally, they were unable to provide the model code of the circuit in use and confirmed that this had been discarded following patient use.Without return of the subject devices fisher & paykel healthcare is unable to confirm if a fisher & paykel healthcare device caused or contributed to the reported event or if a device malfunction occurred.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.The user instructions which accompany the airvo 2 provide guidance for managing condensate and instruct the user that "if excess condensate accumulates in the heated breathing tube, disconnect the patient interface from the heated breathing tube, drain the condensate by lifting the patient end of the tube, allowing the condensate to run into the water chamber".

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18480985
• MDR Text Key: 332488809
• Report Number: 9611451-2024-00012
• Device Sequence Number: 1
• Product Code: BTT
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female