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

Model Number PT101

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in belgium reported via a fisher and paykel healthcare (f&p) field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning.There was no patient consequence.

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

Ps(b)(4).The pt101 airvo 2 humidifier 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.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The airvo 2 speaker is intended to provide auditory alerts to the user and auditory alarms under certain conditions.The alarm system functionality must be checked prior to each patient use.The user instructions warn "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative".In the case of speaker failures, a speaker will typically provide a distorted, intermittent or reduced sound level before becoming completely inaudible over time.This contributes to the early detection of this fault by users.It should also be noted that in the event of a speaker failure during use, the airvo 2 will continue to deliver therapy as per the set parameters.For any alarm condition, the device simultaneously displays a visual alarm alongside auditory alarms and so in the absence of an audible alarm due to speaker failure, a visual alarm will still be displayed.Method: the complaint airvo 2 was received at fisher & paykel healthcare (f&p) in new zealand.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the pt101 airvo 2 humidifier had no audible alarm.Conclusion: we are unable to determine the cause of the failure mode in this instance.

Event Description

A healthcare facility in belgium reported via a fisher and paykel healthcare (f&p) field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning.There was no patient consequence.

• 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: 13884007
• MDR Text Key: 295613858
• Report Number: 9611451-2022-00259
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2101337085(11)201013
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101337085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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