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

Model Number PT101

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject device is no longer in use by the healthcare facility.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.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.

Event Description

A healthcare facility in new york reported that a pt101 airvo 2 humidifier did not have an audible alarm.There was no patient involvement.

Event Description

A healthcare facility in new york reported that a pt101 airvo 2 humidifier did not have an audible alarm.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

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.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.Method: the complaint airvo 2 was received by fisher & paykel healthcare (f&p) where it was inspected by a trained f&p employee.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the airvo 2 had no audible alarm.The device was opened and the complaint speaker was replaced with a known working speaker.The airvo 2 still had no audible alarm, and further testing revealed that the control pcb was faulty.Upon further inspection, it was found that the speaker enclosure had been damaged and the original airvo 2 speaker, which is a supplied component and assembled into the airvo 2, had been replaced with another speaker of unknown origin or manufacturer.The replacement speaker had different specifications to the original airvo 2 speaker and so it is likely to have caused the control pcb to become faulty and thus the airvo 2 to have no audible alarm.Conclusion: it was concluded that the reported event occurred due to the replacement of the original airvo 2 speaker with a speaker of a different specification and of unknown origin and manufacturer.The pt101 airvo 2 technical manual warns that "under no circumstances should the airvo 2 be opened or any of the six fastening screws on the underneath side of the device be loosened." additionally, the pt101 airvo 2 humidifier device label contains the following warning: "do not loosen or remove any case screws".Similarly, the pt101 airvo 2 user instructions also note that "this device contains no internal serviceable parts" 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." f&p has since been in contact with the healthcare facility to advise against opening the device and replacing any internal components as per our labelling.

• 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: 14691719
• MDR Text Key: 302960922
• Report Number: 9611451-2022-00558
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100409260(11)180205
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: 2100409260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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